FDA Adverse Event
Malfunction
Summary report: N
LENSX LASER SYSTEM
MDR report key: 24893121
·
Received April 16, 2026
Report
- Report Number
- 2028159-2026-00500
- Event Type
- Malfunction
- Date Received
- April 16, 2026
- Report Date
- May 7, 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
- FL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
CORRECTED INFORMATION PROVIDED IN G.1., AND H.11. PRODUCT MANUFACTURER DETAILS HAVE BEEN 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 GANTRY WAS MOVING DOWN ON ITS OWN INTERMITTENTLY IN THE UNKNOWN EYE OF THE PATIENT DURING UNKNOWN TIMING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 305078 | LENSX LASER SYSTEM | OPHTHALMIC FEMTOSECOND LASER | OOE | ALCON LENSX, INC. | 550 | NA | 00380659981623 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |