MAUDE Adverse Event Report: AMO UPPSALA AB UNK_OVD_HEALON DUET; AID, SURGICAL, VISCOELASTIC

Model Number	10290080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Corneal Clouding/Hazing (1878); Visual Impairment (2138); Eye Burn (2523)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported that the needle started smoking inside the patient's eye, which caused the iris to fluff and led to a corneal burn.Customer noted that she did not hear the beep that usually signals a rise in temperature.Additional information was received, patient required extensive suturing at the end of the case to achieve wound closure.Sutures were removed.Patient resulted with a corneal scar, astigmatism but correctable to 20/20.No additional surgery required.Phaco settings: vacuum low: 200, high: 350, power: 40%.Whitestar on yes.Mode & subsettings designations, peristaltic, continuous, 8/4, 67%, 83pps.Bottle height: 100 in/cm.Incision size: 2.4mm.Doctor's phaco technique: divide & concur.Model & serial number of equipment: console: signature pro, serial number: (b)(6) (incorrect number), handpiece: ellips fx, sn# not available.Tubing type: opo73, tip: 21g blue.Viscoelastic: duet.This report is for healon duet.Other reports were submitted for whitestar, phaco handpiece, phaco tip, phaco tubing.No further information was provided.
Additional Manufacturer Narrative
Section a2, a4 and a5: unknown, not provided.Section d4 - lot #: unknown/ not provided.Section d4 - udi #: unknown as product lot number was not provided.Section d6a - implant date: not applicable.The material is not an implantable device.Section d6b - explant date: not applicable.The material is not an implantable device.D10 concomitant medical products and therapy dates medical products - whitestar, phaco handpiece, phaco tip, phaco tubing section h3 - the device was not returned for evaluation and the lot for this device is unknown/not provided; therefore, no further product investigation can be performed.Should any further relevant information become available a supplemental medwatch will be filed.Section h4: device manufacture date: unknown as product lot number was not provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: UNK_OVD_HEALON DUET
• Common Device Name: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): AMO UPPSALA AB; rapsgatan 7; uppsala, uppsala län 754 5 0; SW 754 50
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 21883702
• Report Number: 3012236936-2025-000111
• Device Sequence Number: 20784402
• Product Code: LZP
• UDI-Device Identifier: 05050474573574
• UDI-Public: (01)05050474573574(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P810031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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: 10290080
• Device Catalogue Number: 10290080
• Device Lot Number: UNKNOWN
• 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: 03/24/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: SEE H11
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown