MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNFOLDER PLATINUM 1 SERIES; LENS, GUIDE, INTRAOCULAR

Model Number	1MTEC30
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device has not been 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.Attempts have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was previously reported that the johnson and johnson(jnj) platinum cartridges are leaving a filmy or sticky it was previously reported that the johnson and johnson(jnj) platinum cartridges are leaving a filmy or sticky substance on the bottom side of the lens when implanting.(manufacturer report number 3012236936-2024-00697).Presently, the surgeon has continued to notice the filmy substance from the coating on the lens more and more.The johnson and johnson account executive joined the customer for several cases and noticed the filmy substance on 8 cases.The filmy substance gets stuck on the bottom side of the iol and the surgeon uses his irrigation/aspiration (i/a) to clear it, remove it.The jnj account executive followed what the technicians were doing, and it was nothing out of the ordinary.The customer uses healon ophthalmic viscosurgical device (ovd) while loading the iol.In a few cases they tried flushing the cartridge with balanced salt solution (bss) prior to ovd to see if that would flush it out.Reportedly, the customer tried just about everything.The doctor pointed out the substance which was visible on the monitor in the operating room (or) but no photos or videos were taken.There were no complications such as capsule tear, vitrectomy or suture required.No further information was provided.Note: the previous case is (b)(6) manufacturer report number 3012236936-2024-00697.The additional eight cases including this one.Case 1 (b)(6) manufacturer report number 3012236936-2025-0000030 case 2 (b)(6) manufacturer report number 3012236936-2025-0000067 case 3 (b)(6) manufacturer report number 3012236936-2025-0000068 case 4 (b)(6) manufacturer report number 3012236936-2025-0000069 case 5 (b)(6) manufacturer report number 3012236936-2025-0000070 case 6 (b)(6) manufacturer report number.Case 7 (b)(6) manufacturer report number 3012236936-2025-0000074.Case 8 (b)(6) manufacturer report number 3012236936-2025-0000076.

• Brand Name: UNFOLDER PLATINUM 1 SERIES
• 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: 21098980
• Report Number: 3012236936-2025-000007
• Device Sequence Number: 12919032
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)250617(10)CP15414
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K081545
• 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): 01/07/2025

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: 06/17/2025
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CP15414
• 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: 12/11/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2024
• 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: IOL ZCB00 21.5 DIOPTER
• Patient Sex: Unknown