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

Model Number	EMERALDC30
Medical Device Problem Codes	Mechanical Jam (2983); Ejection Problem (4009)
Health Effect - Clinical Codes	Eye Injury (1845); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon further review, it was noted that in the initial mdr section h-6, did not include health effect - clinical code: 1845.Therefore, clinical code information is captured in this supplemental filing.No other information was provided.The following section has been updated accordingly: section h-6 health effect - clinical code: 1845 - eye injury.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: 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: 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 report will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the non pre-loaded ar40e model intraocular lens (iol) was stuck in the emeraldc30 cartridge.Although the extent of patient contact is unknown, contact did occur.An unplanned vitrectomy was performed however, there was no patient injury.The procedure was successfully completed using another iol.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: 19743382
• Report Number: 3012236936-2024-000196
• Device Sequence Number: 7776502
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)241103(10)CM34031
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2024

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 Expiration Date: 11/03/2024
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CM34031
• 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: 06/27/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2023
• 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).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown