MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. IRRIGATION/ASPIRATION TIP; UNIT, PHACOFRAGMENTATION

Model Number UNKNOWN

Device Problem Material Deformation (2976)

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

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

Model number is unknown as it was not provided.Lot number is unknown as it was not provided.A complete unique identifier (udi) number unknown as product lot number was not provided.Telephone: (b)(6).Manufacturer date is unknown as lot number was not provided.Device evaluation: product was not available for further evaluation.Therefore, no testing could be performed.The reported event cannot be confirmed.Manufacturing records review: the lot number was not reported and cannot be obtained.Therefore, complaint history review cannot be performed.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

During a cataract procedure, the surgery center reported a loose tip during procedure.A description from the surgery center indicated while aspirating a hard nucleus, the aspiration became weak.To resolve the aspiration issue, the tubing cassette and handpiece were replaced.After the replacement of the accessories, a 501-prime excessive vacuum and a 285-loose tip error occurred during the cataract procedure.At the advice of technical support, the phaco tip was replaced.The tip replacement resolved the issue.The procedure was completed.No patient injury reported.

• Brand Name: IRRIGATION/ASPIRATION TIP
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 11716035
• MDR Text Key: 250182750
• Report Number: 2020664-2021-07028
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1