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

Model Number	GAB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, 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 d6a - implant date: not applicable, as there is no indication that the lens was implanted.Section d6b - explant date: not applicable, as there is no indication that the lens was implanted.Section e1 - telephone number: (b)(6).Device evaluation: visual inspection of the complaint device revealed that the lens was stuck in the cartridge.Ophthalmic viscosurgical device (ovd) was not observed to be distributed evenly throughout the cartridge, indicating that an inadequate amount of ovd may have been used, which may have contributed to the lens becoming stuck in the cartridge.The cartridge tip was observed to be damaged and cracked.The lens module was opened and inspected, and no issues were identified.The lens could not be removed from the cartridge.No further issues were identified.The complaint issue "cartridge crack" was not identified during product evaluation.The observed "cartridge tip cracked/damaged" is similar to the reported complaint issue.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 could not be confirmed to be related to the manufacturing or design process.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.No escalation required.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.
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) cartridge was broken.The incident involved contact with the eye; however, only the cartridge contacted the eye, not the lens.There was no harm to the patient, and a backup lens was used.The material was returned, and the investigator confirmed that the crack was at the tip with no indication of user error or handling issues identified.No further information was provided.

• 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: 22611015
• Report Number: 3012236936-2025-000188
• Device Sequence Number: 5418726
• Product Code: HQL
• UDI-Device Identifier: 05050474621824
• UDI-Public: (01)05050474621824(17)270411
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P980040
• 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): 07/25/2025

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: GAB00
• Device Catalogue Number: GAB0000220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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
• Patient Sex: Unknown