FDA Adverse Event
Injury
Summary report: N
CRYSTALENS HD IOL
MDR report key: 2901180
·
Received January 4, 2013
Report
- Report Number
- 2031924-2013-00003
- Event Type
- Injury
- Date Received
- January 4, 2013
- Date of Event
- September 19, 2012
- Report Date
- December 5, 2012
- Manufacturer
- BAUSCH + LOMB
- Product Code
- NAA
- PMA / PMN Number
- P030002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LENS IS IMPLANTED, THEREFORE IT IS NOT AVAILABLE FOR EVAL. 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 ANTERIOR VAULTING OF THE LENS WAS NOTED AT THE CLINICAL EXAM APPROX 18 MONTHS POST IMPLANT. THE REFRACTION CHANGED FROM SPHERICAL EQUIVALENT OF +0.25 TO -1.00. YAG WAS PERFORMED ON (B)(6) 2012 ON INFERIOR HINGE OF THE IOL. SUBSEQUENTLY PRK WAS PERFORMED ON (B)(6) 2012. BCVA WAS 20/25-3 S ON (B)(6) 2012. THIS EVENT PERTAINS TO THE PT'S RIGHT EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 4523 | CRYSTALENS HD IOL | NAA/LENS,INTRAOCULAR,ACCOMMODATIVE | NAA | BAUSCH + LOMB | HD520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |