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

Model Number	TG85ML
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The healon gv pro is not an implantable device.If explanted; give date: n/a (not applicable).The healon gv pro is not an implantable device.The device is not returned; therefore, a failure analysis of the complaint device cannot be completed.A review of the device record and complaint trending 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 customer used healon gv pro and noticed white specs in the patient's eye.The white specs seemed to come out during irrigation/aspiration (i/a).The lens was implanted fine.As of now, no known visual issues.No known patient injury.No other information was provided.
Additional Manufacturer Narrative
Additional information: products were not returned however two images of the alleged particle were provided.Analysis of the images did not reveal any relevant information regarding the complaint event.The non-conformance /deviation within the device history record is unrelated to the issue reported by the customer.As a result there is no indication of a product quality deficiency.All devices meet material, assembly, and performance specifications at the time of product release.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: aug.25, 2022.Section h3: device evaluated manufacturer? yes.Device evaluation: complaint sample consisted of a glass cylinder and a plunger rod attached.No healon solution remaining.As no material finds were found within the complaint sample, no instrumental analysis for identification of any foreign material was carried out.The material finds observed by the customer were not returned for analysis.Based upon the visual inspection of the returned product, there is no indication that the customer's observation is due to an issue with the healon gv pro product.Therefore, the customer's report is not confirmed by this investigation.As this investigation has not observed the foreign material reported by the customer, then no product defect (material finds in the solution) can be confirmed.Based upon the visual inspection of the returned product, there is no indication that the customer's observation is due to an issue with the healon gv pro product.Therefore, the customer's report is not confirmed by this investigation and no product defect has been observed.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 complaints per global complaint trending.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: 14887780
• Report Number: 3012236936-2022-01682
• Device Sequence Number: 17480772
• Product Code: LZP
• UDI-Device Identifier: 05050474651654
• UDI-Public: (01)05050474651654(17)240228(10)UJ31169
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: TG85ML
• Device Catalogue Number: 10240014
• Device Lot Number: UJ31169
• 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: 06/10/2022
• Supplement Date Received by Manufacturer: 08/09/2022; 01/10/2023
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 08/09/2022; 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown