FDA Adverse Event
Malfunction
Summary report: N
LENSX LASER SYSTEM
MDR report key: 6113837
·
Received November 18, 2016
Report
- Report Number
- 3008772169-2016-00792
- Event Type
- Malfunction
- Date Received
- November 18, 2016
- Date of Event
- October 26, 2016
- Report Date
- February 2, 2017
- Manufacturer
- ALCON LENSX, INC.
- Product Code
- OOE
- PMA / PMN Number
- K101626
- Removal / Correction Number
- 2016-010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Additional Manufacturer Narrative · 1
INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A DOCTOR REPORTED DURING A LASER ASSISTED CORNEAL FLAP PROCEDURE, THE SIDE CUTS COULD NOT BE OPENED. THE ABLATION TREATMENT WAS CANCELED. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S RIGHT EYE AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 764084 | LENSX LASER SYSTEM | OPHTHALMIC FEMTOSECOND LASER | OOE | ALCON LENSX, INC. | 550 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other |