LIQUID OPTICS INTERFACE
Report
- Report Number
- 3012236936-2024-000207
- Event Type
- Malfunction
- Date Received
- July 25, 2024
- Report Date
- July 28, 2025
- Manufacturer
- JOHNSON & JOHNSON SURGICAL VISION, INC.
- Product Code
- OOE
- UDI-DI
- 05050474609778
- PMA / PMN Number
- K170322
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION: LOT NUMBERS OF THE DEVICES AND QUANTITY 21141253 (X1). 21776752 (X1). 21937490 (X1). 21937495 (X1). 22062546 (X1). 22255649 (X1). 22255677 (X2). 22255678 (X2). 22255681 (X1). 22437557 (X1). 22499917 (X1). 22595436 (X1). 22595442 (X1). 22595456 (X2). 22815141 (X1). 22844421 (X1). 22844423 (X1). 22990479 (X2). 23012645 (X2). 23121216 (X1). 23246668 (X2). 23246675 (X1). 23246676 (X1). 23246678 (X1). 23246679 (X1). 23520806 (X3). 23520807 (X1). 23520808 (X1). 23630125 (X1). 23714524 (X3). 23774113 (X1). 24036203 (X1). 24130025 (X1). 24194378 (X1). ONE (1) INVESTIGATION WAS COMPLETED DURING THE PERIOD. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, RISK DOCUMENTATION AND DEVICE HISTORY RECORD (DHR) SHOWED THAT ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
DEVICE EVALUATION: TWELVE (12) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, TRENDING, RISK DOCUMENTATION AND DEVICE HISTORY RECORD (DHR) SHOWED THAT THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
CORRECTION: DURING A REVIEW OF CASES IT WAS DETERMINED 3 EVENTS WERE INADVERTENTLY CLASSIFIED AS THE REPORTABLE MALFUNCTION OF SUCTION LOSS WHILE LASER FIRING. HOWEVER, THE SUCTION ISSUE OCCURRED DURING THE OPTICAL COHERENCE TOMOGRAPHY STEP OF THE PROCEDURE WHICH IS DONE PRIOR TO LASER FIRING. THE TOTAL NUMBER OF EVENTS INITIALLY REPORTED UNDER THIS MEDWATCH, WHICH WAS (B)(4), IS NO LONGER CORRECT. THE NEW TOTAL OF EVENTS IS (B)(4). IN ADDITION, THE LOT NUMBER INVOLVED IN THE 3 EVENTS IS LOT 23520806 AND NOT THE EVENTS ASSOCIATED TO THAT LOT ARE NONE. SECTION H1, NO. OF EVENTS SUMMARIZED, HAS BEEN UPDATED TO (B)(4). DEVICE EVALUATION: TWENTY-TWO (22) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, RISK DOCUMENTATION AND DEVICE HISTORY RECORD (DHR) SHOWED THAT ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
DEVICE EVALUATION: ONE (1) INVESTIGATION WAS COMPLETED DURING THE PERIOD. THE PRODUCT WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED PRODUCT DID NOT REVEAL ANY OBVIOUS DEFECTS OR DAMAGE. FUNCTIONALITY TEST WAS PERFORMED, AND THE RESULT WAS FOUND NOT WITHIN SPECIFICATIONS. THE REPORTED EVENT IS CONFIRMED. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND DEVICE HISTORY RECORD (DHR) SHOWED THAT THE DEVICE AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
THIS REPORT SUMMARIZES 45 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO SUCTION LOSS WHILE LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 922314 | LIQUID OPTICS INTERFACE | OPHTHALMIC FEMTOSECOND LASER | OOE | JOHNSON & JOHNSON SURGICAL VISION, INC. | 0180-1201 | 05050474609778 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |