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

Model Number	1MTEC30
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Corneal Abrasion (1789)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that cartridge tip was damaged and caused corneal scratch on patient eye.No further information available.
Additional Manufacturer Narrative
Section a2, a3, a4, a5 and a6: unknown; information not provided.Section d6a: if implanted, give date: not applicable as this is not an implantable device.Section d6b: if explanted, give date: not applicable as this is not an implantable device.Section e1: title, email address, state, post office or zip code: unknown, information not provided.Section e1: telephone number: (b)(6).Section h3: evaluated by manufacturer: yes customer provided photos were evaluated.The photo shows the suspect cartridge and the cartridge tip could be observed to be damaged.A lens was also observed to be stuck in the cartridge.Due to no product received, no further evaluation was performed.The complaint issue cartridge tip cracked/damaged was identified during photo evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Hra (health risk assessment) and human risk factor documents were reviewed for the complaint issue reported.The results of this hra and human risk factors review do not confirm that the above situations occurred during manufacturing, and are only provided for informational purposes; therefore, no further escalations are required.Based on the complaint investigation results, the product was released within specifications.Therefore, no product deficiency or product malfunction could be identified.No nonconformity report, documentation or labeling changes, and further escalations are required.Johnson & johnson surgical vision will continue to monitor these types of complaints.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Date returned to manufacturer: 28 aug 2025.Section h3: device evaluated by manufacturer: yes.Visual inspection under magnification was performed on the suspect product and found viscoelastic residue was distributed throughout the cartridge.Stress marks were observed on the cartridge tip and the cartridge tip was damaged.The cartridge was also observed to be damaged.Customer provided photos were evaluated.The photo shows the suspect cartridge and the cartridge tip could be observed to be damaged.A lens was also observed to be stuck in the cartridge.No further evaluation was performed.The complaint issue cartridge tip cracked/damaged was identified during photo and product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Based on the complaint investigation results, the product was released within specifications.Therefore, no product deficiency or product malfunction could be identified.No nonconformity report, documentation or labeling changes, and further escalations are required.Johnson & johnson surgical vision will continue to monitor these types of complaints.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 22448097
• Report Number: 3012236936-2025-000187
• Device Sequence Number: 20911793
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)260317(10)CA29573
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: 03/17/2026
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CA29573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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