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

Model Number	GAB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when positioning the preloaded intraocular lens (iol), an optical defect was noticed on the edge of the lens.The iol was implanted and remains in the patient's eye.According to the customer, the lens was left in the eye with no plan to be removed.The patient does not have any symptoms.No further details were provided.
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, as lens remains implanted.Section e1 - telephone number: (b)(6).Section h3 : the intraocular lens (iol) was not returned for evaluation as it remains implanted.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section h3 - device evaluated by manufacturer? yes.Device evaluation: the intraocular lens (iol) was not returned for evaluation as it remains implanted; however, a photograph was provided by the customer for evaluation.The photograph showed an eye implanted with the suspect lens and a chip like mark could be observed on the edge of the lens.Based on previous clinical advice, due to the location and characteristics of the mark on the edge of the lens, it is not expected for the mark to impact the optical function of the lens; however, the definitive impact and incident root cause cannot be determined from a photograph assessment.Since no product has been received, no further evaluation was performed.The complaint issue "lens 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: 21608030
• Report Number: 3012236936-2025-000059
• Device Sequence Number: 8868268
• Product Code: HQL
• UDI-Device Identifier: 05050474621763
• UDI-Public: (01)05050474621763(17)270628
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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: GAB0000190
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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