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.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.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search for related complaints from lot number uj31048 from the last 12 months was conducted.No related complaint(s) found for "dc-foreign material - loose".Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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
Section d9: device available for evaluation? yes.Returned to manufacturer on: aug.23, 2022.Section h3: device evaluated manufacturer? yes.Device evaluation: complaint sample consisted of a glass cylinder and a plunger rod attached at the bottom of it (tip rubber plunger).No expellable healon solution left in the cylinder.No other product samples were provided.A large number of colorless fibers were observed on the surfaces of the glass cylinder and pushrod.Micro-spectroscopic analysis of the material finds seen was carried out.The material was spectrally similar to a material identified as ¿natural cotton¿.The material is identified as cellulose.The reported issue of white specs could not be confirmed.Visual & stereomicroscopic investigations have not observed any non conformity in the returned product which could explain the customer's report.Cellulose is not used in the production areas at manufacturing site; specifically the cleanroom clothes, cleaning equipment, autoclave bags etc.Do not contain cellulose.Therefore there is no indication that this material has been introduced during the production of the healon products at the manufacturing site.The in process controls of the components, the semi-finished products and the finished products would capture this type of material find contamination and reject the products and components.Therefore no product defect (material finds in the solution) can be confirmed.Conclusion: 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: 14888062
• Report Number: 3012236936-2022-01681
• Device Sequence Number: 20394417
• Product Code: LZP
• UDI-Device Identifier: 05050474651654
• UDI-Public: (01)05050474651654(17)240131(10)UJ31048
• 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
• 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: 01/31/2024
• Device Model Number: TG85ML
• Device Catalogue Number: 10240014
• Device Lot Number: UJ31048
• 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: 01/10/2023
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2021
• 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