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

Model Number	690880
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4 and a5: unknown/ not provided.D10 - concomitant - whitestar sn (b)(6), phaco tip unknown lot number.Section h3: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot 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, 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 or Problem Description
It was reported that the system primed and tuned correctly prior to the case but during phaco, the machine was giving the occlusion sound (dinging) although the machine was not occluded.At that point, the doctor applied more phaco power than needed.He thought there must have been some lens material occluding the tip (that was the signal for him to depress the foot pedal to apply power).As a result of this, a wound burn occurred on the patient's right eye.Doctor tried flushing the handpiece with saline, assuming it was occluded somewhere, but it flushed normally.After this, the doctor tried using the handpiece again and had the same issue.They reran the prime and tune which gave an error for "loose handpiece." they then got another handpiece which primed and tuned correctly and finished the phaco portion of the procedure normally.Doctor could not get the main incision to seal with aggressive hydration (due to the wound burn), so ultimately placed a suture.The patient has done very well.No additional information has been provided.This report is against the handpiece.A separate report will be filed against the tip.
Additional Manufacturer Narrative
Additional information: section a4: 145 pounds section a5: native hawaiian or other pacific islander asian, not hispanic/not latino section b3 date of event: nov 4, 2024 section d4 serial number: (b)(6).Section d4 udi#: (b)(4).Customer reported that the handpiece is not being returned for investigation.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Additional Manufacturer Narrative
Section h3 device evaluated by manufacturer: yes.Section h4 device manufacture date: jun 8, 2016.Device evaluation: the product was evaluated by technician during field service.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.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.

• Brand Name: ELLIPS FX PHACO HANDPIECE
• Common Device Name: 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: 20828236
• Report Number: 3012236936-2024-000322
• Device Sequence Number: 8865363
• Product Code: HQC
• UDI-Device Identifier: 05050474537132
• UDI-Public: (01)05050474537132
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K981116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2025

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
• Operator of Device: Health Professional
• Device Model Number: 690880
• Device Catalogue Number: 690880
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 12/11/2024; 01/28/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/03/2025; 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander