FDA Adverse Event
Injury
Summary report: N
TECNIS CL
MDR report key: 3022067
·
Received March 26, 2013
Report
- Report Number
- 2648035-2013-00130
- Event Type
- Injury
- Date Received
- March 26, 2013
- Date of Event
- December 20, 2012
- Report Date
- February 28, 2013
- Manufacturer
- ABBOTT MEDICAL OPTICS
- Product Code
- HQL
- PMA / PMN Number
- P880081
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(6). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). VISUAL INSPECTION OF THE RETURNED LENS REVEALED A RETURNED IOL THAT WAS TORN IN HALF, WITH ONLY ONE HALF OF THE LENS RETURNED WITH EVIDENCE OF VISCOELASTIC. PLACEHOLDER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) WHICH WAS REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO A WEAK CAPSULAR BAG. IT WAS STATED THAT THERE WAS VITREOUS LOSS. IT WAS STATED THAT A VITRECTOMY WAS PERFORMED AND A MODEL ACD21D3 LENS WAS IMPLANTED. NO INCISION ENLARGEMENT WAS MADE. NO ADDITIONAL COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124512 | TECNIS CL | MONOFOCAL IOLS | HQL | ABBOTT MEDICAL OPTICS | Z9002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |