MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US ELLIPS FX PHACO HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number 690880

Device Problem Overheating of Device (1437)

Patient Problems Eye Burn (2523); Unspecified Eye / Vision Problem (4471)

Event Date 10/06/2023

Event Type  Injury  

Manufacturer Narrative

Section a2, a4 and a5: per regulation eu (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d4 - expiration date: does not apply.Section d6a - implant date: not applicable.Phaco handpiece is not an implantable device.Section d6b - explant date: not applicable.Phaco handpiece is not an implantable device; therefore, not explanted.Section e1 - telephone number: (b)(6).Section h6 -health effect - clinical code: 4471: enlargement of incision.Section h3 - other (81): the material was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during the cataract operation, the surgeon initiated phacoemulsification and the tip of the handpiece abnormally heated and caused a corneal burn and an abnormal enlargement of the incision.This occurred during the first groove phase.The phaco test functioned normally, and the handpiece was initially at a cool temperature.The surgery was stopped to replace the tip and handpiece.The patient's current condition includes two sutures placed following the incision burn.No further information was provided.

• Brand Name: ELLIPS FX PHACO HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. - US; 7500 centurion parkway; jacksonville FL 32256
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18244022
• MDR Text Key: 329431224
• Report Number: 3012236936-2023-02895
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474537132
• UDI-Public: (01)05050474537132(17)991231(10)E234250
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K981116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 690880
• Device Catalogue Number: 690880
• Device Lot Number: E234250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2017
• 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