FDA Adverse Event
Injury
Summary report: N
TECNIS
MDR report key: 3052190
·
Received April 11, 2013
Report
- Report Number
- 2648035-2013-00160
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- February 21, 2013
- Report Date
- March 19, 2013
- Manufacturer
- ABBOTT MEDICAL OPTICS
- Product Code
- HQL
- PMA / PMN Number
- P990080
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.
Additional Manufacturer Narrative · 1
THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER. VISUAL EXAMINATION SHOWED THE LENS HAD SURFACE RESIDUALS ADHERED TO BOTH SIDES OF OPTIC BODY COMPATIBLE WITH HANDLING LENS IN AN UNSTERILE ENVIRONMENT. DIOPTER VERIFICATION: OPTICAL INSPECTION RESULTS SHOWED THAT THE LENS DIOPTER CORRESPONDS TO A 26.0 DIOPTER LENS. THE PRODUCT MET THE ACCEPTANCE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INTRAOCULAR LENS IN THE LEFT EYE WAS SWITCHED BECAUSE THE SURGEON FELT THAT THERE WOULD BE A BETTER OUTCOME WITH A DIFFERENT LENS POWER. RESULT OF NEW IMPLANT WAS GOOD; NO COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155630 | TECNIS | MONOFOCAL IOLS | HQL | ABBOTT MEDICAL OPTICS | ZA9003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |