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

Model Number	GCB00
Medical Device Problem Codes	Crack (1135); Material Fragmentation (1261); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
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 d6b - explant date: not applicable - lens remains implanted; therefore, not explanted.Section e1 - telephone number: (b)(6).Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending 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 missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the plastic rim of the preloaded monofocal intraocular lens (iol) system broke during lens injection inside the eye of the patient, resulting in a fragment of the cartridge being released into the eye.The customer indicated experiencing resistance while advancing the lens through the cartridge.They noted that a similar incident had previously occurred.The lens itself remained intact and was successfully implanted without damage or patient injury.No further information has been provided.A separate report is being submitted to capture the other occurrence of the same issue.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 29-dec-2025.Section h3 - device evaluated by manufacturer? yes.Device evaluation: visual inspection revealed that the smartload device was received with viscoelastic residue distributed throughout the cartridge.The cartridge tip was observed to be cracked and damaged.No issues were observed with the lens module and device assembly.Photographs provided by the customer were evaluated.The photographs displayed the suspect cartridge.The cartridge tip was observed to be torn and damaged; with the torn piece loose and separated from the cartridge tip.The complaint issue "cartridge tip cracked/damaged" was identified during product and photograph evaluation.The complaint issue "product loose particles" 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.The complaint issue "difficult to use" was not identified during product evaluation.Conclusion: based on the complaint investigation results, no product deficiency or product malfunction were found.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: 23846044
• Report Number: 3012236936-2025-000315
• Device Sequence Number: 9572150
• Product Code: HQL
• UDI-Device Identifier: 05050474620698
• UDI-Public: (01)05050474620698(17)280627
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: GCB00
• Device Catalogue Number: GCB0000245
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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