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	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after implantation of the intraocular lens (iol), there was small, clear piece of plastic in front of the lens.The piece was removed with forceps without issues and the patient did not require any further treatments.The patient will be checked when the 2nd eye will be operated.No further details were provided.
Additional Manufacturer Narrative
Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.If explanted, give date: not applicable, device not explanted.Telephone number: unknown / not provided.The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot 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, 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.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 26-jan-2023.Section h-3: device evaluated by manufacturer: yes.Device evaluation: product was returned to the manufacturing site.The alleged foreign material was received on a sponge for evaluation.No further materials were received.Evaluation of the returned product was conducted under magnification.The material and the sponge were sent to a third party laboratory for analysis.The material was identified to be consistent with a mixture primarily containing polypropylene, along with a salt species similar to sodium hyaluronate and possibly sodium cellulose sulfate.The complaint issue of foreign material - loose was identified during product evaluation; subsequent further evaluation is going to be conducted by the manufacturing site smes (subject matter experts) to determine if the complaint issue can be confirmed to be related to a manufacturing process issue.Conclusion: based on the complaint investigation results, further evaluation by the manufacturing site is required, and will be conducted accordingly.All pertinent information available to johnson & 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: 15955407
• Report Number: 3012236936-2022-02879
• Device Sequence Number: 7334525
• Product Code: HQL
• UDI-Device Identifier: 05050474620643
• UDI-Public: (01)05050474620643(17)250916
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 06/23/2023

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: 09/16/2025
• Device Model Number: GCB00
• Device Catalogue Number: GCB0000220
• 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: 11/16/2022
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2022
• 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