CRYSTALENS ACCOMMODATING IOL
Received Jul 7, 2022 · Event occurred Apr 21, 2022
Report 0001313525-2022-00090 · MDR key 14943508
Device
Generic name
Lens, Intraocular, Accommodative
Manufacturer
Bausch + LombModel number
AO2UVCatalog number
AO2UV-1650
Lot number
222
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
69 YR · Male
- Capsular Bag Tear
- Capsular Bag Tear
Narrative
Additional Manufacturer Narrative
ALTHOUGH REQUESTED, THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. THE DEVICE HISTORY RECORD (DHR) REVIEW DID NOT FIND ANY ANOMALIES OR NON-CONFORMITIES RELATED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, USER RELATED FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.
Description of Event or Problem
REPORTEDLY, DURING A CATARACT SURGERY, THE CAPSULAR BAG WAS BROKEN TOWARDS THE END OF THE PROCEDURE. THE LENS WAS THEN REMOVED FROM THE RIGHT EYE, A VITRECTOMY WAS PERFORMED, AND ANOTHER MODEL LENS WAS IMPLANTED. THE OUTCOME WAS REPORTEDLY GOOD.