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	06/22/2023
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, as lens remains implanted.Section e1: email address: unknown/not provided, as information was asked but it was not provided.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 had implanted a metal part into the patient's eye together with the intraocular lens (iol).The metal part was removed.Through follow-up we learned that the lens remained implanted and that there is no indication of any patient issues.No further details were provided.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: september 19, 2023.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the product was returned to the manufacturing site for evaluation.No iol was received as it remains implanted.The alleged foreign material was received wrapped in gauze and in a baggie.Patient stickers and the original folding carton were also received.Analysis of the foreign material received determined that the material is primarily a titanium alloy (likely ti-6al-4v or ti64).This sample was further evaluated.Based on the evaluation performed, the unfolder vitan¿ inserter is composed of titanium.Lens module, shipping tray and cartridge components were verified confirming that there is no presence of titanium alloy consistent with ti6alv4 as part of the manufacturing process of the product.Therefore, it was ruled out that the material belongs to the device.Based on the evaluation performed, the manufacturing process contains the controls to identify and discard units with the defects.Also, production order data shows that there were no deviations on equipment or process contributing to the condition reported.Based on the assessment performed, the complaint reported could not be confirmed by the manufacturing site.Furthermore, the supplier confirmed that the compound mentioned above is not used for this product contact surfaces.The complaint issue of 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: 17334753
• Report Number: 3012236936-2023-01707
• Device Sequence Number: 15356978
• Product Code: HQL
• UDI-Device Identifier: 05050474621817
• UDI-Public: (01)05050474621817(17)260306
• 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: 2023
• 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): 12/19/2023

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: 03/06/2026
• 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: 06/22/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2023
• 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