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

Model Number TH85ML

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Endophthalmitis (1835)

Event Date 11/20/2021

Event Type  Injury  

Manufacturer Narrative

If implanted, give date: not applicable as healon is not an implantable device.If explanted, give date: not applicable as healon is not an implantable device.Therefore, it was not explanted.Telephone number: (b)(6).Device evaluation: product testing could not be performed because the product was not returned (the device was discarded).Therefore, a failure analysis of the complaint device cannot be completed and the reported event cannot be confirmed.Manufacturing record evaluation: the manufacturing records for the product were reviewed and no related deviation or non-conformance was initiated during the manufacturing process.The product was manufactured and released according to specification.A search for related complaints from the lot involved from the last 12 months was conducted and no related complaints were found.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that after a surgery on a patient's left eye on (b)(6) 2021, the patient developed endophthalmitis two days later, on (b)(6) 2021.During the surgery, several medications/products had been used, including healon.At the time of reporting the patient was being treated with antibiotics at a separate hospital from where the operation was performed.There were no complications noted during the procedure or the following day during his post op follow-up telephone call and the patient stated that his vision had improved during this call.It was indicated that the product was discarded following the surgery as there were no complications.No further information was reported.

• Brand Name: HEALON PRO
• Type of Device: 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: 13029629
• MDR Text Key: 286864487
• Report Number: 3012236936-2021-00302
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474701571
• UDI-Public: (01)05050474701571(17)240531(10)UJ31368
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/17/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: TH85ML
• Device Catalogue Number: 10290012
• Device Lot Number: UJ31368
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENDOSOL, LOT 21D0204
• Patient Outcome(s): Required Intervention
• Patient Sex: Male