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

Model Number	GCB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
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 d6b - explant date: not applicable, lens remains implanted.Section e1 - telephone number: (b)(6).Section h3 - other (81): the intraocular lens (iol) was not returned for evaluation.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 and possible product return and evaluation, 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 the surgeon noticed a metal splint being injected into the eye, at the same time as the intraocular lens (iol) was being inserted.The metal splint was removed.No information was provided about any patient complications.The issue was first identified during implantation / application.The iol was fully inserted and no medications were reported.Through follow-up we learned that there was no resistance felt during lens preparation.It is unknow if the foreign material came from the lens or the inserter.No patient injury was reported.No further information was provided.A separate report will be submitted for the inserter involved.
Additional Manufacturer Narrative
Additional information: section d9.Device available for evaluation? yes.Section d9: returned to manufacturer on: 29-may-2024.Section h3.Device evaluated by manufacturer? yes.Device evaluation: the intraocular lens (iol) was not returned for evaluation as the iol remains implanted.Therefore, a fiber like material was received taped to a piece of foam.The fiber was evaluated by a third party laboratory.Foreign material evaluation revealed that the material is primarily a titanium alloy (ti-6al-4v or ti64), with trace levels of na and fe.The inserter used with the smartload device to inject the lens is composed of titanium; however, the inserter was not returned for evaluation.The analysis results of the returned fiber, unused unfolder vitan inserter, and laminar flow phaco tip were reviewed.The review concluded that the source of the foreign matter cannot be confirmed as there are multiple potential sources of titanium alloy during the surgical procedure.The complaint issue "foreign material - loose" was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.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: 19076425
• Report Number: 3012236936-2024-00981
• Device Sequence Number: 12368269
• Product Code: HQL
• UDI-Device Identifier: 05050474620612
• UDI-Public: (01)05050474620612(17)260929
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 01/14/2025

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 Expiration Date: 09/29/2026
• Device Model Number: GCB00
• Device Catalogue Number: GCB0000205
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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