FDA Adverse Event
Injury
Summary report: N
ELASTIMIDE LENS
MDR report key: 276491
·
Received May 2, 2000
Report
- Report Number
- 2023826-2000-00010
- Event Type
- Injury
- Date Received
- May 2, 2000
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT UNDERWENT CATARACT SURGERY ON 3/23/2000, AND IMPLANTATION OF A STAAR MODEL AQ2017V INTRAOCULAR LENS. AS THE LENS WAS INSERTED INTO THE EYE THE CAPSULE TORE. AT THIS TIME, AN ANTERIOR VITRECTOMY WAS PERFORMED. THERE WAS NOT PT INJURY AND THE PT IS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELASTIMIDE LENS | INTRAOCULAR LENS | HQL | STAAR SURGICAL CO. | AQ2017V | 1138908 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |