FDA Adverse Event
Injury
Summary report: N
SERIES TWENTY THOUSAND LEGACY
MDR report key: 174511
·
Received June 26, 1998
Report
- Report Number
- 2028159-1998-00178
- Event Type
- Injury
- Date Received
- June 26, 1998
- Date of Event
- May 29, 1998
- Report Date
- May 29, 1998
- Manufacturer
- ALCON LABORATORIES, INC.
- Product Code
- HQE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
H-10: REC'D COMPLETED QUESTIONNAIRE FROM CUSTOMER. THIS REPORT WAS MAILED IN TO FDA ON: 07/29/1998. THE MFR'S INTERNAL REFERENCE NUMBER IS: 6-11745-1-98. DISCLAIMER: THIS INFORMATION 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
MODERATE BURN; ONE SUTURE REQUIRED TO CLOSE WOUND. ONE WEEK POST-OP CORNEA CLEARING. NOTED FAILURE OF SLEEVE ON HANDPIECE OR COOLING PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERIES TWENTY THOUSAND LEGACY | OPHTHALMIC SURGERY SYSTEM | HQE | ALCON LABORATORIES, INC. | STTL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |