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

Model Number EMERALD CARTRIDGE-THERMOFORM TR, 30 BX

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2024

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 339247223
• Report Number: 3012236936-2024-00955
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)240921(10)CM31939
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1