MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC VERITAS ADVANCED INFUSION PACK; UNIT, PHACOFRAGMENTATION

Model Number VRT-AI

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

Patient Problem Endophthalmitis (1835)

Event Date 02/14/2023

Event Type  Injury  

Manufacturer Narrative

Age, weight, ethnicity: unknown/ not provided.Patient information cannot be provided due to personal data privacy legislation/policy.Initial reporter telephone number: unknown, information not provided.Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record evaluation: based on the manufacturing records review, and historical complaint review, there is no indication of a product malfunction or product quality deficiency.No nonconformity report, documentation or labeling changes, and escalations are required.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that patient who had cataract surgery with veritas ai tubing pack was diagnosed with endophthalmitis.No further information available.This report is 3 of 6.

Manufacturer Narrative

Initially the event date was reported as 2/15/2023.Additional information was received, and it was learnt that out of 6 patients which were initially reported to have experienced endophthalmitis, first 5 patients had surgery on (b)(6) 2023 between 9 am and 3 pm local time and 6th patient had surgery on (b)(6) 2023.Since this report is for patient 3 of 6 patients the event date has been corrected to 2/14/2023.It was also reported that the hospital is strict about the cleaning process and has performed in-house culture test for all the materials used (including phaco pack, ovd {ophthalmic viscoelastic devices} and bss {balanced salt solution} with same lot number used for all these surgeries, nothing was found from the culture test so not sure if it was due to phaco handpiece.Reportedly if it was a cleaning process issue, same issue might have happened with patients who had cataract surgery in the same operating room as device from another manufacturer was used by other physicians afterwards.Bss from another manufacturer was used and new bottles were used for each patient.No further information was provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: VERITAS ADVANCED INFUSION PACK
• 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: 16542225
• MDR Text Key: 311287851
• Report Number: 3012236936-2023-00609
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 35050474700902
• UDI-Public: (01)35050474700902(17)251125(10)60416304
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K203060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VRT-AI
• Device Catalogue Number: VRT-AI
• Device Lot Number: 60416304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2022
• 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
• Patient Outcome(s): Other