FDA Adverse Event
Injury
Summary report: N
ALCON LABORATORIES, INC.
MDR report key: 952162
·
Received November 8, 2007
Report
- Report Number
- 952162
- Event Type
- Injury
- Date Received
- November 8, 2007
- Date of Event
- October 26, 2007
- Report Date
- November 7, 2007
- Product Code
- HQL
- Report Source
- User Facility report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ALCON INTRAOCULAR LENS IMPLANTED IN LEFT EYE IN 2007. PATIENT DID NOT TOLERATE IMPLANT. PHYSICIAN QUESTIONS IF LENS IS DEFECTIVE VERSES PATIENT INTOLERANT TO BRAND. REPLACE EXPLANT WITH AN AMO BRAND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALCON LABORATORIES, INC. | INTRAOCULAR LENS | HQL | SN6AD3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |