Devices

Tecnis Monofocal Silicone Posterior Chamber IOLs (Models: Z9000 and Z9001)

Model / Serial
Tecnis¿ Silicone Z9000, 94 lenses Tecnis Mono 12mm Z9000+11,5 8160800508 Tecnis Mono 12mm Z9000+23,0 8014050508 Tecnis Mono 12mm Z9000+12,0 8110100508 8014060508 8110110508 8014070508 Tecnis Mono 12mm Z9000+20,5 8095430509 8014090508 Tecnis Mono 12mm Z9000+21,0 8062320509 8014100508 Tecnis Mono 12mm Z9000+22,0 8094140509 8014110508 8094150509 8014120508 Tecnis Mono 12mm Z9000+22,5 8080300509 8014130508 8080310509 8014140508 8117480508 8014150508 Tecnis Mono 12mm Z9000+23,0 8012330508 8014160508 8012340508 8014190508 8012360508 Tecnis Mono 12mm Z9000+23,5 8160360508 8012370508 Tecnis Mono 12mm Z9000+24,0 8166940508 8012380508 8166960508 8012400508 8166970508 8012410508 8012430508 8012440508 8012450508 8012460508 8012470508 8012480508 8012510508 8012530508 8012540508 8013910508 8013920508 8013930508 8013940508 8013950508 8013960508 8013970508 8013980508 8013990508 8014000508 8014010508 8014020508 8014030508 8014040508 Tecnis Mono 12mm Z9000+24,5 8037770508 8037780508 8037790508 8037800508 8037810508 8037820508 8037830508 8037840508 8037850508 8037860508 8037870508 8037880508 8037890508 8037900508 8037910508 8037920508 8037930508 8037940508 8037950508 8037960508 8037970508 8037980508 8037990508 8163880508 8163890508 8163900508 8163910508 8163920508 8163930508 8163940508 8163950508 8163960508 8163970508 8163980508 8163990508 8164000508 8164010508 8164020508 Tecnis¿ Silicone Z9001, 13 lenses Tecnis Mono 13mm Z9001+22.5 8030920508 8030930508 8031100508 8031110508 8031130508 8031140508 8031150508 Tecnis Mono 13mm Z9001+25,5 8111960508 8111970508 8111980508 8111990508 8112000508 8112020508
Product Classification
Ophthalmic Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide, Austria, Belgium, Switzerland, Germany, Denmark, France, UK, Guadelope, Hong Kong, Croatia, India, Italy, Netherlands, and Vietnam
Product Description
Tecnis Monofocal Silicone Posterior Chamber IOLs (Models: Z9000 and Z9001)
Manufacturer
Advanced Medical Optics, Inc.
1 Event
- Recall of Tecnis Monofocal Silicone Posterior Chamber IOLs (Models: Z9000 and Z9001)

Manufacturer

Advanced Medical Optics, Inc.

Manufacturer Address
Advanced Medical Optics, Inc., 1700 E Saint Andrew Pl, Santa Ana CA 92705-4933
Source
USFDA

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