MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SMARTLOAD; INTRAOCULAR LENS

Model Number	GCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded monofocal intraocular lens (iol) was implanted.After the implantation, the surgeon identified that one of the haptics on the iol was fractured or faulty.Consequently, the lens was removed, cut, and replaced with the same model of iol.No further information was provided.
Additional Manufacturer Narrative
Additional information: section h3 - device evaluated by manufacturer? yes device evaluation: no suspect product was received; however, a customer provided photograph was evaluated.The photograph showed an eye implanted with the suspected complaint lens.The haptic was observed to be damaged.There was a cut at the haptic optic junction; but the haptic was still attached.No further issues were identified.As no product was been received, no further evaluation was performed.The complaint issue "haptic damaged" was identified during photograph evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: SMARTLOAD
• Common Device Name: INTRAOCULAR LENS
• 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: 23045658
• Report Number: 3012236936-2025-000227
• Device Sequence Number: 13272901
• Product Code: HQL
• UDI-Device Identifier: 05050474620643
• UDI-Public: (01)05050474620643(17)280116
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P980040
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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 Model Number: GCB00
• Device Catalogue Number: GCB0000220
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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