MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC ELLIPS FX PHACO HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number	690880
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3, a4 and a5: information requested but not provided.Section e1: phone number: (b)(6).Information about patient post op status and any treatments has been requested but not provided.Clinical specialist was also on site and reviewed the recordings of surgery, noticed the incision size was bit smaller for the tip used.Device evaluation: the device was not returned for evaluation; therefore, no testing could be performed.The reported event cannot be confirmed.A review of the device history record showed that the device meet material, assembly, and performance specifications at the time of product release.Based on the information obtained, there is no indication of product malfunction or product deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that patient had cataract procedure in the left eye and a corneal burn occurred during the sculpt part of the procedure.The incision size was 2.4 mm.Several jnj products were used: veritas console, phaco handpiece, phaco tip sleeve and veritas vrt-ai pack.Surgeon used alcon bag balanced salt solution.There were no system errors but it was reported that there were excessive bubbles in the chamber during sculpting.No product is being returned.This report is for the ellips fx phaco handpiece product.

• Brand Name: ELLIPS FX PHACO HANDPIECE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 25291122
• Report Number: 3012236936-2026-000150
• Device Sequence Number: 10085847
• Product Code: HQC
• UDI-Device Identifier: 05050474537132
• UDI-Public: (01)05050474537132
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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
• Was Device Available for Evaluation?: No
• 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: 04/29/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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: Other
• Patient Sex: Unknown