CRYSTALENS ACCOMMODATING IOL
Received Sep 1, 2023 · Event occurred Sep 14, 2017
Report 0001313525-2023-70105 · MDR key 17670695
Device
Generic name
Lens, Intraocular, Accommodative
Manufacturer
Bausch + LombModel number
AO1UVCatalog number
AO1UV-2500
Lot number
7643622
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
57 YR · Male
- Capsular Contracture
- Blurred Vision
- Halo
- Capsular Contracture
- Blurred Vision
- Halo
Narrative
Additional Manufacturer Narrative
THE LENS REMAINS IMPLANTED, THEREFORE, WAS NOT PHYSICALLY EVALUATED. A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT FIND ANY NON-CONFORMITIES OR ANOMALIES RELATED TO THIS EVENT. THE TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. BASED ON THE INFORMATION PROVIDED, THE PROBABLE CAUSE OF THIS EVENT WAS DUE TO PATIENT-RELATED FACTORS.
Description of Event or Problem
A CONSUMER REPORTED APPROXIMATELY THREE WEEKS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE THEY EXPERIENCED BLURRY VISION, GLARE, AND HALOS. APPROXIMATELY ONE MONTH AFTER IMPLANTATION, THE SURGEON PERFORMED YAG. THE CONSUMER REPORTS THEY HAVE MONOVISION. IN THE IMPLANTING SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS THE UNPREDICTABILITY OF EFFECTIVE LENS POSITIONING AND PATIENT'S EXPECTATIONS. SURGEON REPORTS PATIENT OUTCOME IS GOOD.
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED.