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

Model Number	EMERALDC30
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a4, a5 patient information: information unknown/not provided.Section b3, date of event: the exact date is unknown.The best estimate is prior to the week of march 06, 2024.Section d6a, if implanted, give date: not applicable as the cartridge is not an implantable device.Section d6b, if explanted, give date: not applicable as the cartridge is not an implantable device, therefore not explantable.Section h3-other (81): the device was not returned for evaluation as it was discarded.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.An attempt was made to obtain the missing information.However, it was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the johnson and johnson(jnj) platinum and emerald cartridges are leaving a filmy or sticky substance on the bottom side of the lens when implanting.Two events were reported against the platinum cartridge and one event against the emerald cartridge.This report captures the emerald cartridge event lot# cm14308.The filmy or sticky substance is causing the doctor to go in and clean off the substance on the bottom of the lens each time it happens.The doctor spoke to his colleague who informed him that these cartridges had the same issue in the past, years ago where it was the coating that is called glycerol monostearate(gms).However, upon further review it was clarified with the customer that the platinum (1mtec30) cartridge is coated with hyaluronic acid (ha) and the emerald cartridge is coated with gms.The customer tried to get a video of what was going on but it was impossible when looking through the microscope as it wasn¿t visible on the viewing monitor.The customer received new cartridges in hopes that it would fix the issue since the issue arose while using older cartridges which were nearing expiration date although not expired.It appear that the issue has not happened again in cases this week (march 2nd ¿ 6th).No other complications were reported such as capsule tear, vitrectomy, incision enlargement or sutures.The iols were left in the eye with no symptoms.The patients are doing well.No further information was provided.One platinum series cartridge event is reported in manufacturer report number 3012236936-2024-00697.The other platinum series cartridge event is reported in manufacturer report number 3012236936-2024-00698.

• 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: 18900244
• Report Number: 3012236936-2024-00699
• Device Sequence Number: 12734360
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)240414(10)CM14308
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2024

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: 04/14/2024
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CM14308
• 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: 02/27/2024
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2023
• 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
• Patient Sex: Unknown