Recall Z-2323-2015— Alcon Research, Ltd.
Class I · Terminated
Class I FDA medical device recall by Alcon Research, Ltd., initiated 2015-04-15, terminated 2017-06-30. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery..
- Recalling firm
- Alcon Research, Ltd.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-04-15
- Terminated
- 2017-06-30
- Firm location
- Fort Worth, TX, United States
Product description
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.
Reason for recall
There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.
Data sourced from openFDA. This site is unofficial and independent of the FDA.