MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC CATALYS SYSTEM; OPHTHALMIC FEMTOSECOND LASER

Model Number	0160-6020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight and ethnicity: unknown/ not provided.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 that during surgery on (b)(6) 2023, doctor had to perform an anterior vitrectomy (after hydrodissection).Cataract procedure was partially completed and an iol was inserted.Secondary intervention from retina will be needed and done at a later date to remove the rest of the cataract.Per doctor this was not related to the catalys.No additional information was provided.

• Brand Name: CATALYS SYSTEM
• 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: 16400828
• Report Number: 3012236936-2023-00387
• Device Sequence Number: 17569381
• Product Code: OOE
• UDI-Device Identifier: 05050474617186
• UDI-Public: (01)05050474617186
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K172002
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0160-6020
• Device Catalogue Number: 0160-6020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male