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

Model Number	IMTEC30
Medical Device Problem Codes	Crack (1135); Device Difficult to Setup or Prepare (1487); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, a4, and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d4 - catalog number: partial number indicated since lot number was not provided.Section d4 - lot #: unknown/ not provided.Section d4 - expiration date: unknown as product serial number was not provided.Section d6a - implant date: not applicable.Cartridge is not an implantable device.Section d6b - explant date: not applicable.Cartridge is not an implantable device.Section e1 - telephone number: unknown / not provided, as information was asked but it was not provided.Section h4 - device manufacture date: unknown, as product lot number was not provided.Device evaluation: product testing could not be performed because the product was not returned.Therefore, a failure analysis of the complaint device cannot be completed, and the reported event cannot be confirmed.Manufacturing record evaluation: the manufacturing record review could not be performed, and complaint history were not reviewed since the lot number is unknown.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during the procedure, the intraocular lens (iol) was implanted, and was tight in the cartridge, causing the cartridge to burst and resulting in a chip on the back surface of the iol.The iol opened more slowly than usual, and the chip was located in the upper eyelid area.The main tunnel incision was not damaged by the ruptured cartridge.The surgeon had to apply additional pressure to push the iol through the cartridge nozzle as the haptics were stuck between the plunger and the cartridge nozzle.The plunger was moving with difficulty.The surgeon expressed concern that the lens did not fully open, did not become flat, and had dents on its surface.Early postoperative treatment results were satisfactory.No additional patient outcomes were reported.No further information was provided.Note: a report is being filed against the lens involved.

• Brand Name: CARTRIDGE PLATINUM
• 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: 24848864
• Report Number: 3012236936-2026-000083
• Device Sequence Number: 21066858
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2026

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 Model Number: IMTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: UNKNOWN
• 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: 03/16/2026
• Initial Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: ICB00 MODEL LENS
• Patient Sex: Unknown