FDA Adverse Event
Injury
Summary report: N
TECNIS CL
MDR report key: 3112671
·
Received May 14, 2013
Report
- Report Number
- 2648035-2013-00217
- Event Type
- Injury
- Date Received
- May 14, 2013
- Report Date
- April 18, 2013
- Manufacturer
- ABBOTT MEDICAL OPTICS
- Product Code
- HQL
- PMA / PMN Number
- P880081
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(6). THE REVIEW OF THE MANUFACTURING DOCUMENTATION AND TESTING WERE FOUND WITHIN PRODUCT SPECIFICATIONS. NO DEVIATIONS OR NON-CONFORMANCES (NCR) WERE GENERATED. BASED ON THE MANUFACTURING RECORD REVIEW, NO DEVIATION OR ASSIGNABLE CAUSE WAS IDENTIFIED WHEN THIS PRODUCTION ORDER WAS MANUFACTURED. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) FAILED AND PATIENT INJURY SUSTAINED. HOWEVER, THERE WERE NO DETAILS PROVIDED AS TO THE FAILURE OF THE INTRAOCULAR LENS (IOL) AND PATIENT INJURY. NO ADDITIONAL INFORMATION COULD BE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 213436 | TECNIS CL | MONOFOCAL IOLS | HQL | ABBOTT MEDICAL OPTICS | Z9002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |