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

Model Number	OPO73
Medical Device Problem Codes	Failure to Prime (1492); Suction Problem (2170)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown, as information was requested but not provided.Section e1 - email address: unknown, as information was requested but not provided section e1 - telephone number: (b)(6).Other (81): the opo73 unit was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Section h6 -health effect - component code: 4756: priming issues.An attempt has been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that when using the opo73 unit, a prime issue (error 501) occurred several times.The pack was reseated several times and priming was performed.There was no suction and when it suddenly started, it damaged the patient's capsule.The physician used a a-vit device intended to treat the capsule rupture.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 08-jul-2024.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the device was investigated and the visual inspection of the returned product did not reveal any obvious defects or damage.The applicable manufacturing records were reviewed by the external manufacturer (flex) for potential discrepancies during the manufacturing process that could contribute to the reported issue.The device history record (dhr) review did not show any potentially related discrepancies and the device lot in question was confirmed to have been manufactured by personnel trained to applicable procedures.Based on the present analysis of the sample, it was determined that the failure mode reported was not confirmed because during the inspection and tests performed, no failures related to incorrect function were detected.No changes in currents controls are required since the process controls are capable of detect this type of failure mode.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction.All pertinent information available to johnson and 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: 19666729
• Report Number: 3012236936-2024-000178
• Device Sequence Number: 6745442
• Product Code: HQC
• UDI-Device Identifier: 15050474602080
• UDI-Public: (01)15050474602080(17)261202(10)60520869
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: OPO73
• Device Catalogue Number: OPO73
• Device Lot Number: 60520869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2023
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian