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

Model Number OPO73

Device Problems Complete Blockage (1094); Failure to Prime (1492); Suction Problem (2170)

Patient Problem Eye Burn (2523)

Event Date 08/16/2022

Event Type  Injury  

Event 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.

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.

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.

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.

• Brand Name: WHITESTAR SIGNATURE PRO
• Type of Device: 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
• MDR Text Key: 300295930
• Report Number: 3012236936-2022-02426
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 15050474602080
• UDI-Public: (01)15050474602080(17)241020(10)60325742
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K151636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPO73
• Device Catalogue Number: OPO73
• Device Lot Number: 60325742
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: OPO73 FUSION DUAL PUMP PACK LOT 60325742
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male