FDA Adverse Event
Injury
Summary report: N
CRYSTALENS ACCOMMODATING IOL
MDR report key: 2802377
·
Received October 19, 2012
Report
- Report Number
- 2031924-2012-00082
- Event Type
- Injury
- Date Received
- October 19, 2012
- Report Date
- August 10, 2012
- Manufacturer
- BAUSCH + LOMB
- Product Code
- NAA
- PMA / PMN Number
- P030002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION OF THIS COMPLAINT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT CRYSTALENS (AT-52AO) INTRAOCULAR LENS WAS IMPLANTED BILATERALLY. APPROXIMATELY 10 MONTHS POST BILATERAL IMPLANTATION THE PT PRESENTED WITH STARBURSTS AT NIGHT. THIS REPORT REFERS TO THE PT'S LEFT EYE. THE PT WAS PRESCRIBED ALPHAGAN FOR TREATMENT. THE PT ALSO HAD BILATERAL YAG CAPSULOTOMIES, AND WAS PRESCRIBED A CONTACT LENS FOR HER RIGHT EYE AND READING GLASSES. PLEASE REFERENCE MDR #: 2031924-2012-00081 FOR INTRAOCULAR LENS FOR THE PT'S RIGHT EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYSTALENS ACCOMMODATING IOL | NAA/INTRAOCULAR LENS | NAA | BAUSCH + LOMB | AT52AO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other | CRYSTALENS ACCOMMODATING IOL AT52AO (B+L) |