FDA Adverse Event
Injury
Summary report: N
CRYSTALENS ACCOMMODATING IOL
MDR report key: 3201676
·
Received June 28, 2013
Report
- Report Number
- 2031924-2013-00109
- Event Type
- Injury
- Date Received
- June 28, 2013
- Date of Event
- April 29, 2013
- Report Date
- May 30, 2013
- Manufacturer
- BAUSCH + LOMB
- Product Code
- NAA
- PMA / PMN Number
- P030002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE LENS REMAINS IMPLANTED IN THE PT'S EYE AND WILL THEREFORE NOT BE RETURNED TO BAUSCH + LOMB 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 THE LENS SHIFTED ANTERIORLY IN THE PT'S LEFT EYE. A YAG LASER TREATMENT WAS PERFORMED APPROX 3 MONTHS POST IMPLANTATION TO ADDRESS THE ANTERIOR SHIFT. THE LENS REMAINS IMPLANTED AND THE PT IS REPORTEDLY "NOT SEEING WELL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297224 | CRYSTALENS ACCOMMODATING IOL | NAA/LENS, INTRAOCULAR, ACCOMODATIVE | NAA | BAUSCH + LOMB | AT50AO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Other |