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

Model Number	GAB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
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, as lens remains implanted.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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a piece of plastic was found in the anterior chamber during intraocular lens (iol) implantation.According to the customer, the piece was clearly not from the lens as the iol was in perfect condition.The plastic piece was removed from the anterior chamber, and the surgery was completed as per the routine.The patient had no adverse effects and there were no complications.No further details were provided.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes, section d9 - date returned to manufacturer: 21-jul-2025, section h3 - device evaluated by manufacturer? yes.Device evaluation: an unknown clear material adhered to the top of the returned tray was received.The tray and material was analyzed and the material was identified as silicone.Smartload device components do not contain silicone material.There are established controls in the manufacturing process to detect loose particles or foreign material in the product and components.Based on the investigation results, no product deficiency was identified.The product was manufactured according to the established procedures and in compliance with their intended use.No discrepancies were found during the manufacturing record review (mrr) related to this complaint.A review of bounding confirmed that there were no additional units affected for similar issues.The reported issue is identified in the product risk management documents.Per the assessment, the reporting rate for similar incidents remains within the acceptable levels.Therefore, no escalation was 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.

• 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: 22048883
• Report Number: 3012236936-2025-000130
• Device Sequence Number: 9061440
• Product Code: HQL
• UDI-Device Identifier: 05050474621817
• UDI-Public: (01)05050474621817(17)280212
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: GAB0000215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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