MAUDE Adverse Event Report: AMO UPPSALA AB HEALON GV PRO; AID, SURGICAL, VISCOELASTIC

Model Number	TG85ML
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Zonular Dehiscence (2698)
Date of Event	11/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot 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, if there is any further relevant information a supplemental medwatch will be filed.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient experienced torn zonules with an ovd (ophthalmic viscoelastic device) and had to have a vitrectomy.No other information was provided.
Additional Manufacturer Narrative
Additional info: additional information was provided and learned the patients outcome.When the patient was discharged on (b)(6) 2022, patient was calm and went directly to another facility for evaluation.The patients date of birth, gender, and weight were provided.No other information was provided.The following sections have been updated accordingly: section a2: age/date of birth: (b)(6) 1942.Section b3: date of event: nov 3, 2022.Section a3: sex/gender: male.Section a4: patient weight: 222 pounds.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: mar.14, 2023.Section h3.Device evaluated manufacturer? yes.Device evaluation: 31 sealed healon gv pro from lot uk31222 were received.Per follow up, customer returned the 31 sealed products due to lost confidence.No suspect product was returned.All returned products were visually inspected and there is no indication that the customer's observation is due to an issue with the healon gv pro product.The customer's report is not confirmed by this investigation and no product defect has been observed, therefore, no probable cause has been determined.Refer to the attached report for further information.Manufacturing record review: per attached dhr summary page provided, no related deviation, ncmr, nc or capa was initiated during the manufacturing process of the reported lot#.All devices meet material, assembly, and performance specifications at the time of product release.Refer to the attached dhr summary page for additional details.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON GV PRO
• Common Device Name: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): AMO UPPSALA AB; rapsgatan 7; uppsala, uppsala län 754 5 0; SW 754 50
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15897651
• Report Number: 3012236936-2022-02965
• Device Sequence Number: 17814941
• Product Code: LZP
• UDI-Device Identifier: 05050474651654
• UDI-Public: (01)05050474651654(17)250430(10)UK31222
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P810031
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2023

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 Expiration Date: 04/30/2025
• Device Model Number: TG85ML
• Device Catalogue Number: 10240014
• Device Lot Number: UK31222
• 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: 11/03/2022
• Supplement Date Received by Manufacturer: 12/07/2022; 04/25/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 12/27/2022; 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2022
• 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: Male
• Patient Weight: 101 KG