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

Model Number	AR40E
Medical Device Problem Codes	Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the sealed packaging was open and during assembly the packaging that normally contains the ar40e model intraocular lens (iol) was loose inside the outer packaging (larger) and there was no iol corresponding to the box.The procedure was completed successfully using a non-johnson & johnson surgical vision iol that was implanted into the patient¿s ocular sinister (left eye) however, there was a delay to obtain another back-up lens.It was confirmed that additional steps were necessary as a consequence of the surgery's delay.Patient outcome post-procedure was reported as excellent.No further information is available.
Additional Manufacturer Narrative
Additional information: section d-6a date implanted: not applicable as the iol was not implanted.Section d-6b date explanted: not applicable as the iol was not implanted, therefore not explanted.Section e-1 reporter telephone number: (b)(6).Field only accepts the us phone number format.Section h3-81: the device was not returned for evaluation.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 & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: no suspect product was received; however, a photo was provided by the customer.The customer provided photo was evaluated.The photo shows the suspect lens case on a table.The lens holder can be observed to be loose from the case, and with no iol observed to be inside.Due to no product being received, no further evaluation could be performed, and no further issues were identified.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: through follow-up, additional information was received stating the daisy wheel was received loose from the case.When it was removed from the sterile packaging, the support that the lens came with was loose from the case and without the lens inside the support.No further information is available.Section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 25-mar-2024.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the daisy wheel was received inside the original folding carton.No lens was received.Visual inspection was performed on the received product.The daisy wheel was received with the lens holder detached.Due to the returned condition of the daisy wheel, no further evaluation could be performed.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR IOL
• 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: 18336310
• Report Number: 3012236936-2023-03178
• Device Sequence Number: 6740338
• Product Code: HQL
• UDI-Device Identifier: 05050474502086
• UDI-Public: (01)05050474502086(17)280316
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00190
• 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: 11/22/2023
• Supplement Date Received by Manufacturer: 02/08/2024; 04/09/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 02/15/2024; 05/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Race: White