FDA Adverse Event
Injury
Summary report: N
CRYSTALENS
MDR report key: 1991107
·
Received February 7, 2011
Report
- Report Number
- 2031924-2011-00007
- Event Type
- Injury
- Date Received
- February 7, 2011
- Date of Event
- August 5, 2010
- Report Date
- December 8, 2010
- Manufacturer
- BAUSCH + LOMB
- Product Code
- NAA
- PMA / PMN Number
- P030002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. ACCORDING TO THE SURGEON, THE LIKELY CAUSE OF THE EVENT WAS DUE TO POOR PERFORMANCE OF THE IOL. THE INTRAOCULAR LENS REMAINS IMPLANTED.
Description of Event or Problem · 1
THE PHYSICIAN REPORTS PERFORMING BILATERAL CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS INTRAOCULAR LENS. THIS REPORT REFERS TO THE RIGHT EYE. APPROXIMATELY SIX WEEKS POSTOPERATIVELY, Z-SYNDROME DEVELOPED IMPACTING THE PATIENT'S VISUAL OUTCOMES. A YAG CAPSULOTOMY WAS PERFORMED TO ADDRESS THE ISSUE. PREOPERATIVELY, THE PATIENT'S PRE-INTERVENTION BCVA WAS 20/30 WITH MR -0.50 - 1.00 X 120. APPROXIMATELY TWO MONTHS AFTER THE YAG APPLICATION, BCVA HAS DECLINED TO 20/50.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYSTALENS | INTRAOCULAR LENS | NAA | BAUSCH + LOMB | AT50AO | 018988 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention | (B)(4) DELIVERY DEVICE (B+L) |