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

Model Number	AR40E
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Failure to Fold (1255)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the haptic had folding issue and was unable to unfold.Iol was removed and replaced.No further information available.
Additional Manufacturer Narrative
Patient information cannot be provided due to personal data privacy legislation/policy section d6a: implant date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: explant date: not applicable, as lens was removed/replaced in the initial surgery.Section h3-other (81): it was indicated that the device is not returning 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
Section d9: device available for evaluation: yes.Date returned to manufacturer: 06 march 2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection of the complaint lens revealed that one haptic was detached and missing.The lens was cleaned, and no further issues were observed.The photographs provided by the customer were evaluated and showed the original folding carton along with a 3-piece lens resting on a medical gauze.The lens appears to have bent/ damaged haptics that are resting across the optic of the lens.Due to the quality of the image, no further product evaluation can be performed.The complaint issue were not identified during product and photograph evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.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 & 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: 18076668
• Report Number: 3012236936-2023-02797
• Device Sequence Number: 12685765
• Product Code: HQL
• UDI-Device Identifier: 05050474502079
• UDI-Public: (01)05050474502079(17)270717
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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 Model Number: AR40E
• Device Catalogue Number: AR40E00185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2022
• 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