MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC UNFOLDER PLATINUM 1 SERIES; LENS, GUIDE, INTRAOCULAR

Model Number	1MTEC30
Medical Device Problem Codes	Break (1069); Crack (1135); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5 and a6: unknown/information 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: 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 records including device history and complaint trending 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.
Event or Problem Description
It was reported by the customer that the non preloaded intraocular lenses(iols) were found damaged inside the cartridges, rendering them unable to be injected and requiring replacement with new lenses.All affected cartridges were identified as belonging to the same lot.It was noted that the damage occurred while the lenses were fully inside the cartridges, with no contact made between the lenses and the patients' eyes, resulting in no adverse effects for the patients.Additional information indicated that a crack in the cartridge had fallen onto the iol after implantation and the tip of the cartridge had been broken.No further information was provided.This report pertained to one of the three cartridges.

• Brand Name: UNFOLDER PLATINUM 1 SERIES
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• 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: 25491904
• Report Number: 3012236936-2026-000177
• Device Sequence Number: 18722707
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)261021(10)CA49488
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K081545
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CA49488
• 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: 05/18/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown