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

Model Number VRT-AI

Device Problem Failure to Prime (1492)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that customer vrt-ai pack had priming issues (failed prime with error 503).Procedure was completed successfully using another pack.There was no patient contact.Product was returned for investigation and results confirmed excessive weld gap.It was also noted that pump tubing at the top of the cassette was slightly twisted contacting the top surface of the cassette.No further information provided.

Manufacturer Narrative

Additional narrative: note: this mdr report is being submitted due to a retrospective review of complaints associated with a remedial action (recall id number: 91290).Section a2, a3, a4, a5: unknown/ not provided.Section d6a/d6b - not applicable, as this is not an implantable device.Section b3: date of event: unknown, not provided, but the best estimate date is between (b)(6) 2022 and (b)(6) 2022.Section h9: johnson & johnson surgical vision (jjsv) has initiated a field action related to the veritas¿ advanced infusion packs (vrt-ai) and veritas¿ advanced fluidics packs (vrt-af) due to the potential for the weld protrusion to be larger than the design specification which could lead to failure during the priming cycle and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during the surgical case.This could result in a delay in surgery and/or longer surgical time, which may result in post-operative ocular sequalae, such as transient corneal edema.Device evaluation: product was returned and evaluated.A visual inspection showed excessive weld gap.The reported event was confirmed.Based on investigation results a product malfunction and product deficiency was confirmed.A nonconformance was initiated to address the weld gap protrusion findings.In addition the peristaltic pump tubing at the top of the cassette was slightly twisted and contacting the top surface of the cassette.The lower drain pump tubing was in contact with the bottom surface of the cassette.Manufacturing record review: a review of the records related to the device was performed.The records showed the device and its components met all specifications prior to being released.Conclusion: as a result of the investigation there is indication of a product quality deficiency.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: 17716002
• MDR Text Key: 323049124
• Report Number: 3012236936-2023-02245
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 35050474700902
• UDI-Public: (01)35050474700902(17)250927(10)60400378
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/08/2023

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
• Device Operator: Health Professional
• Device Model Number: VRT-AI
• Device Catalogue Number: VRT-AI
• Device Lot Number: 60400378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2247-2023
• Patient Sequence Number: 1