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

Model Number	OPO73
Medical Device Problem Codes	Complete Blockage (1094); Failure to Prime (1492); Suction Problem (2170)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported equipment presented prime excessive vacuum error 501 during the fourth patient procedure with the same kit on a patients left (os) eye.Customer informed that performed the exchange of the tubing pack, performed the prime/tune and when resuming the procedure, the error repeated and during the attempts, the incision burned.Customer informed that the surgery had to be completed on the backup equipment and lens was implanted in the capsular bag.Prime/tune test performed with the 2 kits used by the customer where error 501 was confirmed.
Additional Manufacturer Narrative
A request for patient demographics was requested.However, no additional information was received.Telephone number: (b)(6).Device evaluation: the system was evaluated by a field service engineer (fse).The fse performed the exchange of the tubing pack.Tested with two service kits without error.Checklist successfully completed.No equipment problem was identified.While at the customer site, the fse observed tubing pack failure/obstruction.Manufacturing record review: the manufacturing records for the device were reviewed.There were no discrepancies or non-conformances experienced during manufacturing.The system and its components met all specifications prior to being released.Conclusion; as a result, of the investigation there is no indication of a product deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Additional Manufacturer Narrative
Additional information: the field service engineer reported that according to the customer, the error occurred during the fourth surgery using the same pack, the customer replaced the pack (same lot) and informed that he performed the prime/tune successfully, however, when resuming the surgery the error occurred again.During the fse service, he was able to confirm the error in the (b)(4) packs used by the customer right when trying to perform the first prime/tune.When the fse testing with his (b)(4) service packs there was no failure and the service checklist was completed with values within the specified.H6 - type of investigation 4111.Based on the above information the following corrections were done: d4 - lot number, udi number, model number, expiration date and catalog number, h4 - manufacturing date, h5 - single use.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Additional Manufacturer Narrative
H6 type of investigation - 3331.H6 investigation findings - 4248.H6 investigation conclusions - 61.Device evaluation: at the time of the investigation, product was not available for evaluation, therefore no testing could be performed.The reported event cannot be confirmed.Initial report indicates that the first of the two opo73 tubing packs had been reused on four patients - this device is intended for single use.If product is received and product evaluation is required, this investigation record will be reopened to document product evaluation results.Per device history records all devices meet material, assembly, and performance specifications at the time of product release.Based on the information obtained, there is no indication of product malfunction or product deficiency.
Additional Manufacturer Narrative
Additional information: section d9.Device available for evaluation? yes.Returned to manufacturer on apr 25, 2024.Section h3.Device evaluated by manufacturer? yes.Device evaluation: the sealed product returned is not the suspect product that customer experienced issues with.Testing was performed as the returned product is of the same lot as the suspect product.A visual inspection of the returned product did not reveal any obvious defects or damage.Functional testing was performed and the result was found within specifications.The reported event could not be confirmed.Based on the information obtained, there is no indication of product malfunction or product deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaint.Corrected data: upon further review it was determined that section h4 device manufacturer date in the supplemental mdr report, the date oct 21, 2021 was inadvertently provided.The correct date is oct 20, 2021.Therefore, this supplemental report is being submitted to provide the correct data.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: WHITESTAR SIGNATURE PRO
• 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: 15457746
• Report Number: 3012236936-2022-02426
• Device Sequence Number: 15167437
• Product Code: HQC
• UDI-Device Identifier: 15050474602080
• UDI-Public: (01)15050474602080(17)241020(10)60325742
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151636
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/20/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/20/2024
• Device Model Number: OPO73
• Device Catalogue Number: OPO73
• Device Lot Number: 60325742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/22/2022
• Supplement Date Received by Manufacturer: 09/29/2022; 11/09/2022; 02/28/2025
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 10/27/2022; 12/06/2022; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2021
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OPO73 FUSION DUAL PUMP PACK LOT 60325742
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male