Events

Recall of AMO PhacoFlex II Model SI40NB, Intraocular Lenses

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Allergan Medical Optics 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
    26712
  • Event Risk Class
    Class 2
  • Event Number
    Z-1036-03
  • Event Initiated Date
    2003-07-02
  • Event Date Posted
    2003-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28235
  • 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
  • Reason
    Post operative complaints of cloudiness in the intraocular lenses.
  • Action
    Notification letters were sent July 2, 2003 to distributors and subdistributors. Customers were sent letters July 3 and 8, 2003.

Device

AMO PhacoFlex II Model SI40NB, Intraocular Lenses
  • Model / Serial
    1011620109 1303290109 1011680109 1309920109 1038960109 1330610110 1039310109 1391120107 1077970111 1391590107 1077990111 1391930107 1104820203 1414530107 1123300203 1430530112 1149800001 1441910105 1162800105 1454360107 1167400105 1454380107 1168730109 1459930105 1189090109 1484520108 1191330109 1484570112 1191500109 1484650108 1192830105 1486950107 1192940105 1501090108 1207160105 1690550106 1213960109 1690810106 1214020109 1780720106 1215950109 1780740106 1216120109 1781220106 1224570111 1781340106 1227610105 1785280202 1232610109 1846620106 1232680109 1896320106 1232760109 1896330106 1237660109 1896420106 1237880109 1974109910 1276430109 9909772334  1010640212 1012010212 1012040212 1286460208 1299700208 1299760208 1299770208 1324100211 1324110211 1324530211 1384980211 1392500211 1408400211 1419200208 1445720211 1663700211 1670870211 1670890211 1672080211 1703760211 1721900211 1797030210 1956470211 1963580210 1990660211 1991080211 1993620211 1993660211 2121580206 2121690206   Known Implanted Lenses  1704120211 1990690211
  • Distribution
    Brazil only.
  • Product Description
    AMO PhacoFlex II Model SI40NB, Intraocular Lenses
  • Manufacturer
    Allergan Medical Optics Inc

Manufacturer

Allergan Medical Optics Inc
  • Manufacturer Address
    Allergan Medical Optics Inc, 1700 E. St.Andrew Place, Santa Ana CA 92799
  • Source
    USFDA