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

Model Number	20005D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Correction: section h4 - device manufacture date: in initial report, the manufacturer date provided was inadvertently reported as 04/06/2015, however the correct date is 04/10/2015.Additional information: application support manager (asm) reported that doctor uses bandage contact lens (bcl) due to epithelial sloughing.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
It was reported that patient presented with loose epithelium and bandage contact lens (bcl) was placed on both eyes.Pre-operatively and intraoperative the doctor uses the following medications; vigamox, naphcon-a, acular, proparacaine mixed with sodium hydroxide solution and betadine preoperatively.Intraoperatively, doctor uses proparacaine mixed with 15 drops of sodium hydroxide solution manufactured by fisher chemical as the topical anesthetic.No additional information was provided.
Additional Manufacturer Narrative
Section a4 and a5: unknown/ not provided.Section d6a: if implanted, give date: not applicable, as the device is not an implantable.Section d6b: if explanted, give date: not applicable, as the device is not an implantable.Device evaluation: application support manager (asm) changed bed energy settings for the system for easier lifts and doctor was happy with current settings.A review of records including device history record and complaint trending 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 & 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
• Manufacturer Contact: somyata nagpal ; 510 cottonwood drive; milpitas, CA 95035 ; 7142478552
• MDR Report Key: 24211228
• Report Number: 3012236936-2026-000029
• Device Sequence Number: 21214266
• Product Code: GEX
• UDI-Device Identifier: 05050474573451
• UDI-Public: (01)05050474573451
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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: 20005D
• Device Catalogue Number: 20005D
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2015
• 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: 41 YR
• Patient Sex: Male