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	04/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown/ not provided.Section h3: a review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported by the customer that the liquid optics interface had suction loss during laser treatment.There was no patient injury or surgical intervention reported.No further information was provided.
Additional Manufacturer Narrative
Correction: h4 device manufacture date: in initial report, the manufacturer date provided was inadvertently reported as 08/30/2021, however the correct date is 08/31/2022.Additional information: section a2: age 84 years old; date of birth (b)(6) 1939.Section a3 gender: female.Section a4 patient weight: 143 pounds.Section a5 ethnicity: not hispanic/latino, white.Section h3: device evaluated by manufacturer: yes.Device evaluation: device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.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: 16863254
• Report Number: 3012236936-2023-01146
• Device Sequence Number: 12248336
• Product Code: OOE
• UDI-Device Identifier: 05050474609761
• UDI-Public: (01)05050474609761(17)230830(10)20644670
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/02/2023

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: 08/30/2023
• Device Model Number: 0180-1401
• Device Catalogue Number: 0180-1401
• Device Lot Number: 20644670
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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: CATALYS S/N: (B)(6)
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White