MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC FS DISPOSABLE INTERFACE; POWERED LASER SURGICAL INSTRUMENT

Model Number	660065AN
Medical Device Problem Codes	Contamination (1120); Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was debris on the patient interface (pi).The procedure was completed with a new pi.No patient injury and/or complications were reported.No additional information was provided.
Additional Manufacturer Narrative
All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information/device evaluation: section h3: device evaluated by manufacturer: yes.Device evaluation: one (1) opened patient interface (pi) was received within original packaging, confirming the reported lot number.A visual inspection of the returned product revealed some debris on the lens of the pi cone, further inspection did not reveal any other obvious defects or damage.How and when the debris was introduced cannot be determined.The reported event was confirmed.Notes on received product stated "could not achieve suction".Functionality test was performed, and the result was found within specifications.The reported suction issue was not confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: based on the information obtained, since the product was received open and it cannot be determined how and when the foreign material was introduced, product malfunction and deficiency cannot be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: FS DISPOSABLE INTERFACE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 18136097
• Report Number: 3012236936-2023-02889
• Device Sequence Number: 7992109
• Product Code: GEX
• UDI-Device Identifier: 05050474535305
• UDI-Public: (01)05050474535305(17)241030(10)60415449
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

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 Expiration Date: 10/30/2024
• Device Model Number: 660065AN
• Device Catalogue Number: 660065AN
• Device Lot Number: 60415449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• 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: 11/09/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LASER S/N: (B)(6).
• Patient Sex: Unknown