FDA Adverse Event
Injury
Summary report: N
TECNIS CL
MDR report key: 2974621
·
Received February 22, 2013
Report
- Report Number
- 2648035-2013-00105
- Event Type
- Injury
- Date Received
- February 22, 2013
- Date of Event
- February 6, 2013
- Report Date
- February 6, 2013
- Manufacturer
- ABBOTT MEDICAL OPTICS
- Product Code
- HQL
- PMA / PMN Number
- P880081
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. THE LENS HAD ONE DETACHED HAPTIC, A TORN OPTIC AND APPEARS TO HAVE EVIDENCE OF OPHTHALMIC VISCOELASTIC ON IT.(B)(4): PLACEHOLDER.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE IMPLANTING AN INTRAOCULAR LENS(IOL) THE DOCTOR NOTICED A HAPTIC WAS DETACHED. THE DOCTOR ENLARGED THE INCISION TO EXPLANT THE LENS. ANOTHER LENS WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE PATIENT IS REPORTED TO BE DOING WELL, NO COMPLICATIONS OR INJURY NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77758 | TECNIS CL | MONOFOCAL IOLS | HQL | ABBOTT MEDICAL OPTICS | Z9002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |