FDA Adverse Event
Injury
Summary report: N
CRYSTALENS
MDR report key: 2030684
·
Received March 18, 2011
Report
- Report Number
- 2031924-2011-00071
- Event Type
- Injury
- Date Received
- March 18, 2011
- Date of Event
- December 1, 2010
- Report Date
- February 18, 2011
- Manufacturer
- BAUSCH & LOMB
- Product Code
- NAA
- PMA / PMN Number
- P030002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE IOL IS IMPLANTED.
Description of Event or Problem · 1
THE PT REPORTS THAT Z-SYNDROME DEVELOPED APPROXIMATELY TWO MONTHS AFTER CATARACT SURGERY WITH BILATERAL IMPLANTATION OF CRYSTALENS IOL. THIS REPORT REFERS TO THE LEFT EYE. THE PT REPORTS THAT HER DISTANCE VISION IS POOR AND SHE WEARS GLASSES FOR CORRECTION. YAG LASER TREATMENT WAS APPLIED WITH NO IMPROVEMENT. NEAR VISION IS GOOD. REFERENCE MDR # 2031924-2011-00070.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYSTALENS | INTRAOCULAR LENS | NAA | BAUSCH & LOMB | AT50AO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other |