FDA Adverse Event
Injury
Summary report: N
DBD-CATARACT EYE PACK
MDR report key: 17613418
·
Received August 24, 2023
Report
- Report Number
- 1423395-2023-00038
- Event Type
- Injury
- Date Received
- August 24, 2023
- Date of Event
- March 8, 2023
- Report Date
- August 24, 2023
- Manufacturer
- MEDLINE INDUSTRIES LP
- Product Code
- OJK
- UDI-DI
- 10195327135829
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
IT WAS REPORTED THAT A PATIENT HAD A PHACOEMULSIFICATION WITH PC IOL WITH ISTENT PLACEMENT ON (B)(6) 2023. ON (B)(6) 2023, REMOVAL OF FOREIGN BODY (WHITE THREAD) WAS REMOVED IN THE OR. NO ADDITIONAL DETAILS WERE PROVIDED. A SAMPLE WAS REQUESTED TO BE RETURNED FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem · 0
A WHITE THREAD WAS REMOVED FROM THE EYE FOLLOWING A PHACOEMULSIFICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1100842 | DBD-CATARACT EYE PACK | OJK | MEDLINE INDUSTRIES LP | 23DDA989 | 10195327135829 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |