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

Model Number	UNK_CARTRIDGE_EMERALD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6: information unknown/not provided.Patient information.Cannot be provided due to personal data privacy legislation/policy.Section d4: model number: unknown, as the lot number was not provided.Section d4: catalog number: unknown, as the lot number was not provided.Section d4: lot number: unknown, information not provided.Section d4: expiration date: unknown as product lot number was not provided.Section d6a: if implanted; give date: n/a (not applicable).The cartridge is not an implantable device.Section d6b: if explanted; give date: n/a (not applicable).The cartridge is not an implantable device.Section e1: first/given name: unknown, as full first name was not provided.Section e1: telephone number: (b)(6).Section h4: device manufacture date: unknown, as the lot number was not provided.Section h6: device code(s): 1069 cartridge damage, 1069 haptic damage.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a monofocal intraocular lens (iol) had its haptic bent due to lens injector malfunctioning.Consequently, the lens was only partially inserted.However, it was also reported that the lens was inserted and removed during the same procedure.A replacement ar40e 23.0 diopter lens with serial number (b)(6) was successfully implanted using a new injector without complications.The procedure was delayed by approximately two minutes.The directions for use were followed, and no unplanned incision enlargement, sutures, or vitrectomy occurred.Details regarding patient outcome and status remains unknown.No additional information about the complaint is available.

• Brand Name: UNK_CARTRIDGE_EMERALD_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: 23986085
• Report Number: 3012236936-2026-000009
• Device Sequence Number: 4578490
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K961242
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2026

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: UNK_CARTRIDGE_EMERALD
• Device Catalogue Number: UNK_CARTRIDGE_EMERALD
• Device Lot Number: UNKNOWN
• 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: 12/11/2025
• Initial Report FDA Received Date: 01/06/2026
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR40E LENS SN (B)(6).
• Patient Sex: Unknown