FDA Adverse Event
Other
Summary report: N
LENSAR LASER SYSTEM -FS 3D
MDR report key: 3877416
·
Received May 29, 2014
Report
- Report Number
- 3009026057-2014-00006
- Event Type
- Other
- Date Received
- May 29, 2014
- Date of Event
- May 6, 2014
- Report Date
- May 21, 2014
- Manufacturer
- LENSAR INC
- Product Code
- OOE
- PMA / PMN Number
- K120214
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IT WAS DETERMINED FROM THE INVESTIGATION THAT THE INCIDENT ROOT CAUSE WAS DUE TO PATIENT MOVEMENT. NO SURGICAL INTERVENTION WAS PERFORMED TO PRECLUDE ANY PERMANENT DAMAGE.
Description of Event or Problem · 1
ON (B)(6) 2014, WHILE A LENSAR CLINICAL APPLICATION SPECIALIST WAS ON SITE FOR A TRAINING, THE DOCTOR LOST SUCTION DURING THE CAPSULOTOMY PROCEDURE AND ENDED UP PARTIALLY ETCHING THE CORNEA AFTER THE PATIENT MOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 316387 | LENSAR LASER SYSTEM -FS 3D | LENSAR LASER SYSTEM -FS 3D | OOE | LENSAR INC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |