FDA Adverse Event
Injury
Summary report: N
TECNIS 1 MULTIFOCAL
MDR report key: 3120902
·
Received May 20, 2013
Report
- Report Number
- 9614546-2013-00080
- Event Type
- Injury
- Date Received
- May 20, 2013
- Date of Event
- March 20, 2013
- Report Date
- April 30, 2013
- Manufacturer
- ABBOTT MEDICAL OPTICS
- Product Code
- MFK
- PMA / PMN Number
- P980040
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PLACEHOLDER.
Additional Manufacturer Narrative · 1
IMPLANT DATE: IF IMPLANTED, GIVE DATE: (B)(6) 2012. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER (PATIENT) WAS UNHAPPY WITH THEIR VISUAL OUTCOME AND THE INTRAOCULAR LENS (IOL) WAS EXPLANTED. IT WAS STATED THAT THE IOL WOULD NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221762 | TECNIS 1 MULTIFOCAL | MULTIFOCAL IOLS | MFK | ABBOTT MEDICAL OPTICS | ZMB00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |