MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. EMERALD CARTRIDGE

Model Number	EMERALD CARTRIDGE-THERMOFORM TR, 30 BX
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a4 and a5: unknown/not provided.Patient information cannot be provided due to personal data privacy legislation/policy.Section d6a: implant date: not applicable, it is not an implantable device.Section d6b: explant date: not applicable, it is not an implantable device.Section e1: email address: unknown/not provided.Section e1: telephone number: (b)(6).Section h3: other 81: 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, complaint trending, and risk documentation 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.
Event or Problem Description
It was reported that the patient suffered from blurred vision in the left eye for a year and underwent phacoemulsification and intraocular lens implantation.During the use of the intraocular lens, it was found that the tip of the cartridge was damaged, but it did not cause harm to the patient.The procedure completed successfully.There was no delay in treatment or other interventions performed.No further information was provided.

• Brand Name: EMERALD CARTRIDGE
• Common Device Name: EMERALD CARTRIDGE
• 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: 19024199
• Report Number: 3012236936-2024-00955
• Device Sequence Number: 14422914
• Product Code: HBF
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)240921(10)CM31939
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/02/2024

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 Expiration Date: 09/21/2024
• Device Model Number: EMERALD CARTRIDGE-THERMOFORM TR, 30 BX
• Device Catalogue Number: EMERALDC30-12
• Device Lot Number: CM31939
• 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: 03/07/2024
• Initial Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• 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