Events

Recall of Device Recall BIOM PACK

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Insight Instruments, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56246
  • Event Risk Class
    Class 2
  • Event Number
    Z-2221-2010
  • Event Initiated Date
    2010-05-12
  • Event Date Posted
    2010-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93054
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ocular Surgery Irrigation Device - Product Code KYG
  • Reason
    Insight instruments, inc., stuart, fl is recalling cornea coat 2.5% hydroxypropylmethylcellulose solution in 1.5 ml syringe due to a potential weakness of the peel pouch seals. products affected are item numbers 600100.000 sold individually and 40201.000 thru 10206.000 sold as components of biom pack.
  • Action
    All consignees were notified of the recall by letter sent via first class mail. Letter contained a Return Response Form.

Device

Device Recall BIOM PACK
  • Model / Serial
    Cornea Coat Lot Codes:  M408080708,  M409570708,  M414420808,  M415940808,  M415950808,  M416620908,  M419300908,  M421610908,  M421680908,  M422951008,  M427661108,  M430041108,  M435381208,  M442120109,  M44499,  M44744,  M44897.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including Puerto Rico, and Frankfurt, Germany.
  • Product Description
    BIOM PACK, Contents Individually Sterile. QTY 5 EA. Each Pack Contains: 1 EA. Microscope Drape (REF40100), 1 EA. Cornea Coat (REF 60010), 1 EA. SuperView BIOM Lens Set (REF 40411). || Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd. Stuart, FL 34994 USA. || Item # 40201: || Item Lot # Cornea Coat Lot # Expiration Date || M423801008 M419300908 2010-07 || M427731108 M419300908 2010-07 || M428631008 M419300908 2010-07 || M434211208 M422951008 2010-08 || M439670109 M422951008 2010-08 || M443700109 M435381208 2010-09 || M44887 M442120109 2010-10 || Item # 40202: || Item Lot # Cornea Coat Lot # Expiration Date || M427641008 M419300908 2010-07 || M45414 M435381208 2010-09 || Item # 40203: || M416600908 M415950808 2010-06 || M422941008 M416620908 2010-07 || M427651108 M422951008 2010-08 || M442710109 M435381208 2010-09 || M44870 M442120109 2010-10 || Item # 40204: || Item Lot # Cornea Coat Lot # Expiration Date || M421580908 M416620908 2010-07 || M435201208 M422951008 2010-08 || M45645 M435381208 2010-09 || Item # 40205: || Item Lot # Cornea Coat Lot # Expiration Date || M410510708 M409570708 2010-05 || M412790708 M409570708 2010-05 || M419280908 M415950808 2010-06 || M420850908 M415950808 2010-06 || M421100908 M416620908 2010-07 || M421120908 M416620908 2010-07 || M424361008 M419300908 2010-07 || M425821008 M421680908 2010-07 || M426731008 M421680908 2010-07 || M428601008 M419300908 2010-07 || M429531108 M421680908 2010-07 || M430851108 M421680908 2010-07 || M431051108 M422951008 2010-08 || M433111108 M422951008 2010-08 || M435531208 M430041108 2010-09 || M440700109 M430041108 2010-09 || M441790109 M435381208 2010-09 || M442560109 M430041108 2010-09 || M443450109 M422951008 2010-08 || M443930109 M442120109 2010-10 || M44605 M442120109 2010-10 || M44896 M44499 2010-11 || M45099 M44499 2010-11 || M45243 M435381208 2010-09 || M45248 M44897 2010-12 || M45866 M44897 2010-12 || M45870 M435381208 2010-09 || Item # 10206: || Item Lot # Cornea Coat Lot # Expiration Date || M418460908 M416620908 2010-07 || M434741208 M422951008 2010-08 || M45646 M435381208 2010-09
  • Manufacturer
    Insight Instruments, Inc.

Manufacturer

Insight Instruments, Inc.
  • Manufacturer Address
    Insight Instruments, Inc., 2580 Se Willoughby Blvd, Stuart FL 34994-4701
  • Manufacturer Parent Company (2017)
    Insight Instruments, Inc.
  • Source
    USFDA