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

Model Number	AR40E
Medical Device Problem Codes	Break (1069); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: sections a-2 patient age/date of birth, a-4 patient weight, and a-5 patient ethnicity and race: unknown/asked information unavailable.Section d-6a date implanted: not applicable as the iol was removed and replaced during the same procedure.Section d-6b date explanted: not applicable as the iol was removed and replaced during the same procedure, therefore not explanted.Section e-1 (b)(6).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.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the ar40e model intraocular lens (iol) haptic was crooked before inserting into the cartridge and the doctor choose to insert the lens.The haptic does not deploy completely inside capsular bag resulting in the iol not being properly held.An attempt is made to accommodate the lens without success, it was decided to remove the lens and replace it.No further information is available.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 03-jan-2024.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the labels, suspect iol and daisy wheel, implant cards, and dfu were received in the folding carton.Visual inspection of the suspect iol found the lens was received cut in half and crushed in the daisy wheel.The lens was cleaned, and visual inspection found edge damage, scratches, surface damage and a bent haptic.No further evaluation was performed.Complaint issue "haptic damaged" 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: based on the complaint investigation results, the product was released within specifications and the reported complaint issues could not be confirmed.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: 18419815
• Report Number: 3012236936-2023-03310
• Device Sequence Number: 15141365
• Product Code: HQL
• UDI-Device Identifier: 05050474502123
• UDI-Public: (01)05050474502123(17)280120
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2024

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: AR40E00210
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 03/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2023
• 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