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

Model Number	AR40E
Medical Device Problem Codes	Break (1069); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as there is no indication that the lens was implanted.If explanted, give date: not applicable, as there is no indication that the lens was implanted therefore it was not explanted.The device is not received; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/ lot history record and complaint trending 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.
Event or Problem Description
It was reported that a ar40e model intraocular lens(iol) was partially inserted and trailing haptic was bent.There was no patient injury and no medical/ surgical interventions such as incision enlargement, vitrectomy or sutures were done.Procedure was completed successfully using backup lens.No further information available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation ¿ yes, returned to manufacturer on 1/8/2022.Section h3: device returned to manufacturer ¿ yes.Device evaluation: visual inspection under magnification revealed that the lens was received with haptic damage.The lens was cleaned, and no further issues were identified.The complaint issue, delivery issue, could not be confirmed.The complaint issue, haptic damaged, could be confirmed; however, it may be attributed to handling during implantation, and cannot be confirmed to be related to a manufacturing issues.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed no other complaints were received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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: 13006813
• Report Number: 3012236936-2021-00209
• Device Sequence Number: 19286841
• Product Code: HQL
• UDI-Device Identifier: 05050474502031
• UDI-Public: (01)05050474502031(17)250417
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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: 04/17/2025
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2022
• 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: 11/22/2021
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EMERALD LOT: CJ17783
• Patient Sex: Unknown