FDA Adverse Event
Injury
Summary report: N
SERIES TWENTY THOUSAND LEGACY
MDR report key: 122285
·
Received September 23, 1997
Report
- Report Number
- 2028159-1997-00150
- Event Type
- Injury
- Date Received
- September 23, 1997
- Date of Event
- August 20, 1997
- Report Date
- August 25, 1997
- Manufacturer
- ALCON LABORATORIES,INC.
- Product Code
- HQE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
H6 CODES ADDED. MISSING OR ORIGINAL SUBMISSION. THIS REPORT WAS MAILED IN TO FDA ON: 9/24/97. THE MANUFACTURERS INTERNAL REFERENCE NUMBER IS: 8-10161-97. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER NOTED CORNEAL BURN DURING QUADRANT REMOVAL. SUTURES REQUIRED TO CLOSE WOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERIES TWENTY THOUSAND LEGACY | OPHTHALMIC SURGERY SYSTEM | HQE | ALCON LABORATORIES,INC. | STTL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |