FDA Adverse Event
Injury
Summary report: N
CRYSTALENS
MDR report key: 1061408
·
Received June 17, 2008
Report
- Report Number
- 2031924-2008-00225
- Event Type
- Injury
- Date Received
- June 17, 2008
- Date of Event
- May 5, 2008
- Report Date
- May 14, 2008
- Manufacturer
- EYEONICS, INC.
- Product Code
- HQL
- PMA / PMN Number
- P030002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED LENS HAS NOT BEEN RETURNED FOR EVAL. HOWEVER, 3 LENSES FROM THE SAME MFG LOT WERE EVALUATED. THE EVAL RESULTS REVEAL THAT ALL 3 LENSES WERE CORRECTLY LABELED AS 23.50 D LENSES.
Description of Event or Problem · 1
THE PHYSICIAN REPORTS THAT A PT UNDERWENT CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS. POSTOPERATIVELY, THE PT'S BCVA DECREASED COMPARED TO PREOPERATIVE BCVA. APPROX. THREE WEEKS POSTOPERATIVELY, SECONDARY SURGICAL INTERVENTION WAS PERFORMED IN ORDER TO EXCHANGE THE LENS FOR A 22.50 D CRYSTALENS. NOW THE PT'S VISION IS POSITIVE IN THE OPPOSITE DIRECTION. THE PHYSICIAN BELIEVES THE ORIGINAL CRYSTALENS DIOPTER WAS MISLABELED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYSTALENS | INTRAOCULAR LENS | HQL | EYEONICS, INC. | AT50SE | 011039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |