MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC ELITA; OPHTHALMIC FEMTOSECOND LASER

Model Number	0155-1001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Corneal Clouding/Hazing (1878)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a flap procedure on 29 january.On the first postoperative day, a slight peripheral haze was noted in the operated eye, not affecting the pupillary area.Medication was prescribed and follow-up was planned.Additional information indicated that the haze had resolved within 15 days after medication.No other information was provided.
Additional Manufacturer Narrative
Section a2, a3, a4, a5 and a6: unknown/not provided.Section d6a: not applicable as the product is not an implantable device.Section d6b: not applicable as the product is not an implantable device.Section e1: initial reporter: email address: unknown, information not provided.Section e1: initial reporter: telephone number: (b)(6).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 and complaint history for production order 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 & johnson surgical vision, inc.Has been submitted.

• Brand Name: ELITA
• Common Device Name: OPHTHALMIC FEMTOSECOND LASER
• 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: 24443691
• Report Number: 3012236936-2026-000053
• Device Sequence Number: 18752661
• Product Code: OOE
• UDI-Device Identifier: 05050474738553
• UDI-Public: (01)05050474738553
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K063682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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: 0155-1001
• Device Catalogue Number: 0155-1001
• 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: 01/30/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2023
• 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 Sex: Unknown