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

Model Number	EMERALDC30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: female was the answer provided.Section d-4 device lot number: unknown as information was not provided.Section d-4 device expiration date: unknown as device lot number was not provided.Section d-4 udi number: the unique device identifier (udi) number is unknown as device lot number was not provided.Section d-6a date implanted: not applicable, as the cartridge is not an implantable device.Section d-6b date explanted: not applicable, as the cartridge is not an implantable device.Section h-3 device evaluated by manufacturer: device lot number is not available; therefore, no further investigation can be performed.The device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.If there is any further relevant information received, a supplemental medwatch report will be filed.Section h-4 device manufacture date: unknown, as device lot number was not provided.Section h-6 device code: 1069 cartridge damage and lens damage.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Patient gender: female.The non pre-loaded ar40e model intraocular lens (iol) was damaged during loading, technician error was reported and issue related to use error was confirmed.The emerald cartridge was the issue that caused the technician to load the iol incorrectly however, the specific cartridge issue was not provided.There was patient contact however, no medical intervention and no surgical intervention was performed during the procedure.No further information is available.

• Brand Name: UNFOLDER EMERALD
• 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: 21131995
• Report Number: 3012236936-2025-000011
• Device Sequence Number: 12508081
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2025

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: EMERALDC30
• Device Catalogue Number: EMERALDC30
• 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: 12/13/2024
• Initial Report FDA Received Date: 01/10/2025
• 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: AR40E IOL SN: (B)(6).
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White