MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. FS DISPOSABLE INTERFACE; POWERED LASER SURGICAL INSTRUMENT

Model Number	660065AN
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot numbers of the devices and quantity 60429453 (x1), 60582341 (x2).Two (2) investigations were completed during the period.A review of the records related to the devices that included labeling, manuals, trending, and device history record (dhr) showed that the devices and its components met all specifications prior to being released.No product deficiency was identified.The patient interface (pi) suction ring may lose suction during a procedure.Label copy states corneal fixation vacuum loss can occur.There are several factors that may contribute to suction issues such as doctor¿s technique in applying the suction ring to the cornea, doctor¿s technique in squeezing the pi clip to secure the suction ring to the pi cone and patient anatomy affecting the interface between the patient¿s cornea and the suction ring.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
This report summarizes 3 malfunction events.The event was related to suction loss while laser firing.There were no patient injuries reported associated to the events.
Additional Manufacturer Narrative
Correction: in the initial 3 additional devices from lot 60656625.The total amount of events reported initially had changed since the devices were incorrectly identified.The correct number of events is 6.All 3 devices are lot number 60656625.Device evaluation: one (1) investigation was completed during the period.A review of the records related to the devices that included labeling and trending showed that the device and its components met all specifications prior to being released.No product deficiency was identified.

• Brand Name: FS DISPOSABLE INTERFACE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 510 cottonwood drive; milpitas, CA 95035 ; 7142478552
• MDR Report Key: 24211246
• Report Number: 3012236936-2026-000022
• Device Sequence Number: 9661935
• Product Code: HNO
• UDI-Device Identifier: 05050474535305
• UDI-Public: (01)05050474535305
• Combination Product (Y/N): N
• PMA/510(K) Number: K060372
• Exemption Number: VMSR
• Number of Events Summarized: 6
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 660065AN
• Device Catalogue Number: 660065AN
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown