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	03/05/2024
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 during implantation of the preloaded monofocal intraocular lens (iol), a small piece of "steel wire" followed the lens into the eye.Account indicated that the lens was not damaged and the foreign material was removed with tweezers.The eye was not affected and the patient was reported as fully recovered.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 11-apr-2024.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection of the device was performed and no issues were identified.A fiber was received inside a specimen vial.Further evaluation of the fiber identified the material as a titanium alloy.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.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.
Additional Manufacturer Narrative
Additional information and corrected data: product investigation was updated, the sentence below was added, relating to the inserter.The inserter used with the smartload device to inject the lens is composed of titanium; however, the inserter was not returned for evaluation.Updated product investigation device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection of the device was performed and no issues were identified.A fiber was received inside a specimen vial.Further evaluation of the fiber identified the material as a titanium alloy.The inserter used with the smartload device to inject the lens is composed of titanium; however, the inserter was not returned for evaluation.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.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 03-jun-2024.Section h3 - device evaluated by manufacturer? yes.Device evaluation: visual inspection of the device was performed and no issues were identified.A fiber was received inside a specimen vial.The fiber was sent out to a third-party laboratory for evaluation.The material was identified as a titanium alloy.The inserter used with the smartload device to inject the lens is composed of titanium; however, the inserter was not returned for evaluation.Unused samples of an unfolder vitan inserter (lot 0015) and laminar flow phaco tip, 21 gauge straight tip (lot 5062516) were provided for material characterization to establish baseline composition of the consumables that may be used in combination with the smartload.Both units were analyzed and confirmed all samples analyzed for the unused inserter and phaco tip were consistent with a titanium alloy.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 deficiency or product malfunction.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: 18983743
• Report Number: 3012236936-2024-00670
• Device Sequence Number: 12820056
• Product Code: HQL
• UDI-Device Identifier: 05050474620704
• UDI-Public: (01)05050474620704(17)260531
• 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,Followup,Followup
• Report Date (Section B): 01/10/2025

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: 05/31/2026
• Device Model Number: GCB00
• Device Catalogue Number: GCB0000250
• 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: 03/05/2024
• Supplement Date Received by Manufacturer: 05/22/2024; 07/12/2024; 12/26/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 05/28/2024; 07/24/2024; 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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