MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. PHACO HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number UNKNOWN

Device Problem Complete Blockage (1094)

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

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

Patient age or date of birth, weight, and ethnicity: unknown, not provided.Serial number: unknown.Model number: unknown.Unique identifier (udi) number: unknown as serial number of handpiece is unknown.Concomitant products: compact intuitiv system, s/n (b)(4) and opo85 multiple-use tubing pack.Device manufacture date: unknown as serial number of handpiece is unknown.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing record could not be reviewed since the serial number was not provided.The risks and mitigations associated with the complaint issue are identified in existing risk or labeling documents and no new issues/risks were identified as part of this investigation.Based on the failure mode, probable cause, risk assessment and/or labeling review of this incident, a product deficiency was not identified.Conclusion: as a result of the investigation and based on limited information available, it cannot be determined if there is a product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that there was a clog during a cataract procedure using a phaco handpiece.A description from the surgery center reported poor vacuum performance in the phaco segment.The blockage was removed by flushing out the tubing cassette and handpiece.The procedure was completed, and no patient injury reported.Through a technical support conversation, it is suspected the tubing cassette had a clog.A johnson & johnson field service representative provided training awareness on cleaning instructions on the use of opo85 reusable tubing cassettes.

• Brand Name: PHACO HANDPIECE
• 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: 11723115
• MDR Text Key: 263205155
• Report Number: 2020664-2021-07025
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2021

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/26/2021
• 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