FDA Adverse Event
Malfunction
Summary report: N
SENSAR
MDR report key: 2943924
·
Received February 5, 2013
Report
- Report Number
- 2648035-2013-00056
- Event Type
- Malfunction
- Date Received
- February 5, 2013
- Report Date
- January 11, 2013
- Manufacturer
- ABBOTT MEDICAL OPTICS
- Product Code
- HQL
- PMA / PMN Number
- P980040
- Removal / Correction Number
- 2648035-01-03-13-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CORRECTED: (B)(6) 2012. PLACEHOLDER.
Additional Manufacturer Narrative · 1
(B)(6). (B)(4). THE PRIMARY CAUSE FOR THIS EVENT WAS THE INADVERTENT SWITCHING OF THE DEVICE HISTORY RECORD (DHR) LABELING POUCHES BETWEEN THE TWO TOTES OF IMPACTED LENSES ON AN IN-PROCESS STORAGE RACK. PLACEHOLDER.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION: (B)(6) YEARS, FEMALE. (B)(6). PLACEHOLDER.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) WHICH IS PART OF A PRODUCT RECALL. ABBOTT ISSUED THE PRODUCT RECALL DUE TO A DIOPTER MIX-UP BETWEEN TWO LOTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 49380 | SENSAR | MONOFOCAL IOLS | HQL | ABBOTT MEDICAL OPTICS | AR40E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |