MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC LIQUID OPTICS INTERFACE; OPHTHALMIC FEMTOSECOND LASER

Model Number	0180-1401
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a4 and a5: information unknown/ not provided.Section h3 - other (81): the liquid optics interface (loi) was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a suction loss occurred during laser fire.The procedure was completed with another liquid optic interface (loi).No defects where observed prior use and no medical interventions where reported.No patient movement was noticed during the issue and no further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes, returned to manufacturer on 04/21/2023 section h3: device evaluated by manufacturer: yes.Device evaluation: one (1) loi was returned within original packaging confirming the reported lot number.Upon inspection, the insert ring was observed to be slightly misplaced.Suction failure was confirmed on the axial proof load test.After realigning the insert ring, the unit passed the axial proof load test.Manufacturing records review: the manufacturing records for the device were reviewed.No deviations, ncs, or capas were initiated during the manufacturing process for this lot number.A search of complaints from lot number 20644673 from the last 12 months was conducted and one (1) related complaint was found.Conclusion: based on the information obtained, product malfunction is confirmed.The insert ring could have moved during use and explains why suction was at first achieved then failed in the field.Awareness and retraining were performed with the assembly team on placement of the insert ring.The defect was assessed as within the expected rate of occurrence and therefore determined to be an isolated event.There was no patient impact reported.Johnson surgical vision will continue to monitor this type of complaints per global complaint trending.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: LIQUID OPTICS INTERFACE
• Common Device Name: OPHTHALMIC FEMTOSECOND LASER
• 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: 16855555
• Report Number: 3012236936-2023-01061
• Device Sequence Number: 12403224
• Product Code: OOE
• UDI-Device Identifier: 05050474609761
• UDI-Public: (01)05050474609761(17)230905(10)20644673
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170322
• 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): 09/15/2023

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: 09/05/2023
• Device Model Number: 0180-1401
• Device Catalogue Number: 0180-1401
• Device Lot Number: 20644673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown