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

Model Number 690880

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Corneal Decompensation (1790); Eye Burn (2523)

Event Date 03/29/2024

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 d6a - implant date: not applicable.Phaco handpiece system is not an implantable device.Section d6b - explant date: not applicable.Phaco handpiece system is not an implantable device; therefore, not explanted.Section e1 - (b)(6).Section h3 - other (81): the device 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 after a difficult cataract operation, with a very hard core, with a phaco veritas, there was a case of corneal burn.We've learned through follow up that 3 sutures were required as hydro-suturing was not possible due to corneal decompensation.The patient recovered after 15 days.The doctor has always been satisfied with véritas, and acknowledges that this cataract was the first of its kind he had operated on.He does not believe that the jnj device was at fault and assumes responsibility.Setting changes were discussed and the following procedure went well.No further detail was provided.

• Brand Name: ELLIPS FX PHACO HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19214510
• MDR Text Key: 341407018
• Report Number: 3012236936-2024-01150
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474537132
• UDI-Public: (01)05050474537132
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 690880
• Device Catalogue Number: 690880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2023
• 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