FDA Adverse Event
Injury
Summary report: N
CRYSTALENS HD IOL
MDR report key: 3010271
·
Received March 13, 2013
Report
- Report Number
- 2031924-2013-00053
- Event Type
- Injury
- Date Received
- March 13, 2013
- Date of Event
- December 12, 2012
- 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 PT PRESENTED WITH DECREASED IN VISION DUE TO ASYMMETRICAL LENS VAULTING OBSERVED 11 WEEKS FOLLOWING IMPLANTATION OF THE IOL. LENS REPOSITIONING WAS PERFORMED ONE WEEK LATER AND CAPSULAR TENSION RING (CTR) WAS PLACED. THE SURGEON INDICATED THAT IN HIS OPINION THE MOST LIKELY CAUSE OF THE EVENT WAS CAPSULAR FIBROSIS. THE PT PROGNOSIS IS GOOD. THIS REPORT PERTAINS TO THE PT'S LEFT EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106379 | CRYSTALENS HD IOL | NAA | BAUSCH + LOMB | HD500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |