Device product
ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.
Z-2323-2015
Product summary
- Event
- Event 71630
- Status
- Terminated
- Classification
- Class I
- Quantity
- 45,391
- Official record key
device-enforcement:Z-2323-2015
Official wording
Reason: There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.
Code information: Model Numbers: SN6AD1, SN6AD3, SV25T0, MN6AD1,SND1T3, SND1T4, SND1T5 and SND1T6 and all lot numbers.
Distribution pattern: Distribution Japan, No US distribution.
Derived failure modes
-
Unknown
There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.