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

Model Number	20005D
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 on (b)(6) 2021 that the ifs z-cal moved during the day and thickness was 130mm.The surgeon reported that a patient had a torn flap from 8 to 10 o'clock on one eye.The flap was put back down and covered with a bandage contact lens.
Additional Manufacturer Narrative
Correction: h4 - manufacturing date - the manufacturing site reported that the manufacturing date for the device is january 27, 2010.Additional information: h6 type of investigation codes 3331, 4110 and 4109.H6 investigation findings: code 213.Device evaluation: a review of the records related to this equipment that included labeling, manual, trending, and risk documentation reviews for this equipment were performed.Equipment labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: FS LASER SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• MDR Report Key: 11337670
• Report Number: 3006695864-2021-07180
• Device Sequence Number: 4502482
• Product Code: GEX
• UDI-Device Identifier: 05050474573451
• UDI-Public: (01)05050474573451
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K063682
• 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 faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20005D
• Device Catalogue Number: 20005D
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention