MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. WHITESTAR SIGNATURE; UNIT, PHACOFRAGMENTATION

Model Number	OPO73
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient had a corneal burn during sculpt and required 4 sutures to close the wound.There was no post-operative complication and no permanent damage to cornea/sclera.The patient has recovered.No additional information was provided.This report is against the opo73.Separate reports will be submitted against the veritas console, ellips handpiece and 21g tip.
Additional Manufacturer Narrative
Section a2, a4 and a5: unknown, as not provided.Section d4: lot number: unknown/not provided.Section d4: model # unknown/not provided.Section d4: catalog # unknown/not provided.Section d4: expiration date: unknown, as the lot number of the device was not provided.Section d4: udi #: a complete udi # is unknown as product lot number was not provided.Section d6a: if implanted, give date: not applicable, as the tubing is not an implantable device.Section d6b: if explanted, give date: not applicable, as the tubing is not an implantable device.Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.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.Section h4: device manufacture date: unknown, as the lot number of the device was not provided.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Additional Manufacturer Narrative
Additional information: a j&j representative spoke with doctor who reported the following information from phone call: doctor reported that when she had the corneal burn on the grade 4 cataract, she says it occurred almost immediately once phaco was engaged, hence in her mind, she believes it could be the endocoat.It was explained that the endocoat as a dispersive is more ¿sticky¿ hence requires more careful removal as described in the direction for use (dfu).All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: WHITESTAR SIGNATURE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 21939557
• Report Number: 3012236936-2025-000123
• Device Sequence Number: 18342958
• Product Code: HQC
• UDI-Device Identifier: 15050474602080
• UDI-Public: (01)15050474602080(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K160236
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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: OPO73
• Device Catalogue Number: OPO73
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/20/2025
• 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: VERITAS SYSTEM, ELLIPS HANDPIECE, 21G TIP, HEALON.
• Patient Sex: Female