FDA Adverse Event
Injury
Summary report: N
CRYSTALENS
MDR report key: 1230039
·
Received November 12, 2008
Report
- Report Number
- 2031924-2008-00313
- Event Type
- Injury
- Date Received
- November 12, 2008
- Date of Event
- May 20, 2008
- Report Date
- October 17, 2008
- Manufacturer
- BAUSCH & LOMB SURGICAL
- Product Code
- HQL
- PMA / PMN Number
- P030002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS.
Description of Event or Problem · 1
A PT REPORTS UNDERGOING CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS IN THE LEFT EYE. APPROXIMATELY TWO-WEEKS POSTOPERATIVELY, THE PT EXPERIENCED GLARE, HALOS, AND STARBURSTS, WHICH IMPACTED NIGHT DRIVING ABILITY. THE PT ALSO REPORTS PAIN IN THE OPERATIVE EYE AND USE OF READING GLASSES. THE PHYSICIAN EXAMINED THE PT, AND NOTED THAT THE LENS WAS WELL CENTERED AND IN GOOD POSITION. THE PT REPORTS UNDERGOING A YAG CAPSULOTOMY, PRESUMABLY FOR TREATMENT OF POSTERIOR CAPSULE OPACIFICATION. ADDITIONAL INFO WILL BE REQUESTED FROM THE PHYSICIAN, ONCE PERMISSION IS GRANTED FROM THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYSTALENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB SURGICAL | AT50SE | 011133 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other |