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

Model Number	EMERALDC30
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the unknown non-preloaded intraocular lens (iol) had marks on surface after implantation.Iol had to be removed during the same procedure.The cartridge was splitting on parts where it folded together.There was incision enlargement and sutures were required.No further information is provided.This report is for the cartridge.A separate report is being submitted for the intraocular lens.
Additional Manufacturer Narrative
Section e1: reporter: 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.
Additional Manufacturer Narrative
Additional information.Section d9: device available for evaluation: no, however, photo was available.Section d9: returned to manufacturer: product was not received, however, photo was received.Section h3: device evaluated by manufacturer: no, however, photo was evaluated.Section h6: adverse event problem: component codes: updated from '4742 - inserter' to '4755 - part/component/sub-assembly term not applicable' device evaluation: a customer photo was provided and evaluated.The photo displays the suspect cartridge packaging and label.No photos of the actual cartridge product was provided.Due to no product received, no further evaluation could be performed and no issues could be identified.Conclusion: the complaint issue "cartridge crack" was not identified during photo evaluation.Therefore, there is no indication of a product deficiency or product malfunction.Based on the complaint investigation results, the product was released within specifications.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 19988287
• Report Number: 3012236936-2024-000225
• Device Sequence Number: 17921059
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)240818(10)CM25681
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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: 08/18/2024
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CM25681
• 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: 07/19/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2023
• 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: ZA9003 LENS (UNKNOWN SERIAL NUMBER).
• Patient Sex: Unknown