FDA Adverse Event
Injury
Summary report: N
CRYSTALENS
MDR report key: 1895388
·
Received November 4, 2010
Report
- Report Number
- 2031924-2010-00192
- Event Type
- Injury
- Date Received
- November 4, 2010
- Report Date
- October 5, 2010
- Manufacturer
- BAUSCH & LOMB
- Product Code
- NAA
- PMA / PMN Number
- P030002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RP
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS HD INTRAOCULAR LENS. TWO MONTHS POSTOPERATIVELY, THE PT PRESENTED WITH LENS VAULTING IN A Z-CONFIGURATION. THE SURGEON PERFORMED SURGICAL INTERVENTION TO REPOSITION THE IOL. THE LENS REPOSITIONING WAS SUCCESSFUL AND THE PT'S VISION IMPROVED. APPROX ONE YR POSTOPERATIVELY, A YAG CAPSULOTOMY WAS PERFORMED. IT SHOULD BE NOTED THAT THIS PT ALSO EXPERIENCED ASYMMETRICAL LENS VAULTING IN THE FELLOW EYE. ADD'L INFO HAS BEEN REQUESTED. REFERENCE MDR 2031924-2010-00193.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYSTALENS | INTRAOCULAR LENS | NAA | BAUSCH & LOMB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |