MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC WHITESTAR SIGNATURE; UNIT, PHACOFRAGMENTATION

Model Number	OPO73
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Corneal Edema (1791); Eye Burn (2523)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: unknown/ not provided section e1 telephone number: (b)(6).Section h3: 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 a corneal burn occurred during sculpt mode after doctor realized she had been performing phaco with the opo73 as the irrigation line had disconnected from her ellipsfx ultrasound hand piece.Line was reconnected and case could be completed.However, sutures had to be made to close the impacted main incision to assure proper wound sealing at end of the procedure.Post op day 1 showed 20/100 visual acuity (va) but on follow up, doctor stated that this is probably secondary to patient's tight sutures as corneal edema on this left eye was very light, she added, not likely to impact va.Signature pro, opo73 and opocr3021l with alcon balanced salt solution (bss) had been used all day without issue.Doctor is very experienced with this system and under these program settings.Doctor relates issue on irrigation line being disconnected for a while, not cooling down her phaco tip.Denied having system or hand piece checked on this matter.No additional information was provided.
Additional Manufacturer Narrative
Additional information: section h3 device evaluated by manufacturer: yes.Section h4 device manufacture date: mar 2, 2024.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19327801
• Report Number: 3012236936-2024-000128
• Device Sequence Number: 15181202
• Product Code: HQC
• UDI-Device Identifier: 15050474602080
• UDI-Public: (01)15050474602080(17)270302(10)60541257
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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: OPO73-12
• Device Lot Number: 60541257
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White