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	05/03/2023
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, lens remains implanted.Section e1 - first/given name: unknown, as information was requested but not provided.Section e1 - telephone number: (b)(6).Device evaluation: product testing could not be performed since the device was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.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: a product deficiency has not been identified; therefore, no additional corrective actions have been initiated.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the surgeon introduced a metal particle into the patient's eye when implanting an intraocular lens (iol).The particle was removed and is available for product investigation.We learned through follow up that the iol remains implanted and that there is no more information on how the patient is doing now.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: august 11, 2023.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the intraocular lens (iol) was not returned for evaluation as it remains implanted.The complaint alleged foreign material was received inside of a bag.The complaint smartload and the smartload tray were also received.The smartload was inspected for additional foreign material and none was identified.The alleged foreign material was sent for fourier-transform infrared spectroscopy (ftir) testing.The sample could not be identified via ftir; therefore energy-dispersive x-ray spectroscopy (edx) was performed, which revealed the sample is a titanium alloy consistent with ti6alv4.Due to ftir being unable to be performed on the foreign material sample, no ftir spectrum could be obtained to be run against the manufacturing process to identify potential sources of the foreign material.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.
Additional Manufacturer Narrative
Additional information: section d9 - date returned to manufacturer: october 11, 2023.Device evaluation: the sample was further inspected upon return to the manufacturing site as the alleged foreign material was previously identified as a titanium alloy consistent with ti6alv4 via energy-dispersive x-ray spectroscopy (edx).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 is ruled out that this material belongs to the device.The manufacturing process contains the controls to identify and discard units with 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 cannot be confirmed by the manufacturing site.Additionally, the supplier certified that to their best knowledge, the compound ti6aiv4 mentioned above is not used in the facility for this product contact surfaces.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: 17015182
• Report Number: 3012236936-2023-01232
• Device Sequence Number: 20590976
• Product Code: HQL
• UDI-Device Identifier: 05050474621855
• UDI-Public: (01)05050474621855(17)260113
• 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,Followup
• Report Date (Section B): 12/14/2023

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: 01/13/2026
• Device Model Number: GAB00
• Device Catalogue Number: GAB0000235
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 09/20/2023; 11/29/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 10/11/2023; 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• 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