MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNK_CARTRIDGE_PLATINUM_UNKNOWN; LENS, GUIDE, INTRAOCULAR

Model Number	IMTEC30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	04/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a non-preloaded three-piece lens was loaded into a butterfly injector.High pressure was noted during delivery, and the trailing haptic kinked.A posterior capsule rent occurred, and the lens was subsequently explanted.A vitrectomy was performed, and medications were prescribed for the posterior capsule rent complications.The procedure was delayed by 30 minutes.No further information was provided.
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5 and a6: unknown/information not provided.Section d4: catalog number: a complete catalog number is unknown, as the serial number was not provided.Section d4: lot number: unknown, information not provided.Section d4: expiration date: unknown, as serial number was not provided.Section d4: unique device identifier (udi #): unknown, as lot number was 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: address: unknown, information not provided.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 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.Section h4: device manufacture date: unknown as lot number was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNK_CARTRIDGE_PLATINUM_UNKNOWN
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 25383710
• Report Number: 3012236936-2026-000162
• Device Sequence Number: 15634907
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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: IMTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown