MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. SOVEREIGN PHACO HANDPIECE

Device Problem Obstruction of Flow (2423)

Patient Problem No Code Available (3191)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Model no.Is unknown as it was not provided, serial no.Is unknown as it was not provided, unique identifier (udi#) is unknown as serial no.Was not provided, phone number (b)(4), manufacturer date is unknown as serial no.Was not provided.No evaluation could be performed as the product was not returned.The serial number of handpiece was not provided; therefore, the manufacturer record could not be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

During phacoemulsification, the phaco handpiece was not able to extract part of the lens, and the patient was hospitalized.There was an incision enlargement of the main corneal incision and a suture was needed to complete the procedure.

• Brand Name: SOVEREIGN PHACO HANDPIECE
• Type of Device: PHACO HANDPIECE
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; 2268 s 3270 w; salt lake city UT 84119 1112
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 11040129
• MDR Text Key: 222622358
• Report Number: 3006695864-2020-00557
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)
• Combination Product (y/n): Y
• Reporter Country Code: CN
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/24/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR