FDA Adverse Event
Injury
Summary report: N
CRYSTALENS HD IOL
MDR report key: 3030311
·
Received March 28, 2013
Report
- Report Number
- 2031924-2013-00061
- Event Type
- Injury
- Date Received
- March 28, 2013
- Date of Event
- January 20, 2013
- Report Date
- February 11, 2013
- Manufacturer
- BAUSCH + LOMB
- Product Code
- NAA
- PMA / PMN Number
- P030002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DECREASE IN VISION AND SYMMETRICAL LENS VAULTING OBSERVED 9 WEEKS FOLLOWING IMPLANTATION OF THE IOL. THE PATIENT UNDERWENT YAG AND LENS POSITIONING. THE SURGEON INDICATED THAT IN HIS OPINION THE MOST LIKELY CAUSE OF THE EVENT WAS CAPSULAR FIBROSIS. THE PATIENT IS DOING WELL AND MAINTAINING GOOD VISION. THIS REPORT PERTAINS TO THE PATIENT'S LEFT EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 129683 | CRYSTALENS HD IOL | NAA/LENS, INTRAOCULAR, ACCOMMODATIVE | NAA | BAUSCH + LOMB | HD500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Other |