FDA Adverse Event
Malfunction
Summary report: N
LENSX LASER SYSTEM
MDR report key: 24981481
·
Received April 24, 2026
Report
- Report Number
- 2028159-2026-00581
- Event Type
- Malfunction
- Date Received
- April 24, 2026
- Report Date
- May 18, 2026
- Manufacturer
- ALCON LENSX, INC.
- Product Code
- OOE
- UDI-DI
- 00380659981623
- PMA / PMN Number
- K163551
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
CORRECTION INFORMATION PROVIDED IN G.1. PRODUCT MANUFACTURING DETAILS UPDATED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Additional Manufacturer Narrative · 0
H.3., H.6.: 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. ALCON LENSX ( (B)(4) IS NO LONGER OPERATIONAL. LENSX MANUFACTURED PRODUCTS ARE MAINTAINED AND INVESTIGATED BY THE ALCON RESEARCH, LTD. IRVINE TECHNOLOGY CENTER (B)(4). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem · 0
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE FLAP RESISTANCE IN THE UNKNOWN EYE OF A PATIENT, DURING REFRACTIVE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 131238 | LENSX LASER SYSTEM | OPHTHALMIC FEMTOSECOND LASER | OOE | ALCON LENSX, INC. | 550 | NA | 00380659981623 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |