FDA Adverse Event
Injury
Summary report: N
CRYSTALENS INTRAOCULAR LENS
MDR report key: 4212961
·
Received October 24, 2014
Report
- Report Number
- 2031924-2014-00277
- Event Type
- Injury
- Date Received
- October 24, 2014
- Report Date
- September 24, 2014
- Manufacturer
- BAUSCH + LOMB
- Product Code
- NAA
- PMA / PMN Number
- P030002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LENS REMAINS IMPLANTED, THEREFORE,IT IS NOT AVAILABLE FOR EVALUATION. INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT YAG WAS PERFORMED DUE TO PCO APPROXIMATELY 3 MONTHS POST LENS IMPLANT. SEVEN MONTHS AFTER YAG TREATMENT THE PATIENT COMPLAINED OF BLURRY VISION. AT EXAMINATION, THE LENS WAS FOUND TO BE PUSHED FORWARD IN FRONT OF THE ANTERIOR CAPSULE WITH FUSION OF THE ANTERIOR AND POSTERIOR CAPSULES AROUND THE PLATES. THE SURGEON IS EVALUATING TREATMENT OPTIONS. THIS REPORT PERTAINS TO THE PATIENT'S LEFT EYE. REFERENCE MDR # 2031924-2014-00276 FOR PATIENT'S RIGHT EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 678895 | CRYSTALENS INTRAOCULAR LENS | LENS, INTRAOCULAR, ACCOMMODATIVE | NAA | BAUSCH + LOMB | AT50AO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |