FDA Adverse Event
Injury
Summary report: N
CELOFTAL
MDR report key: 3941011
·
Received June 30, 2014
Report
- Report Number
- 3002037047-2014-00074
- Event Type
- Injury
- Date Received
- June 30, 2014
- Date of Event
- January 1, 2014
- Report Date
- June 3, 2014
- Manufacturer
- ALCON - BELGIUM/ ALCON N.V.
- Product Code
- LZP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE WAS RECEIVED BY MANUFACTURING FOR EVALUATION. BATCH RECORD REVIEW SHOWED THAT ALL TESTING RESULTS ARE WITHIN SPECIFICATION. NO OTHER ADVERSE REACTIONS HAVE BEEN REPORTED SO FAR FOR THE REPORTED LOT. SINCE NO COMPLAINT SAMPLE IS AVAILABLE, NO FURTHER EVALUATION CAN BE PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THAT EXPIRED PRODUCT WAS USED DURING A PROCEDURE. THE PATIENT PRESENTED WITH POST-OPERATIVE INFLAMMATION WHICH WAS TREATED AND CONTROLLED WITH OCULAR DROPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 378899 | CELOFTAL | AID, SURGICAL, VISCOELASTIC | LZP | ALCON - BELGIUM/ ALCON N.V. | NA | 12B22D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |