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

Model Number	AR40E
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight and ethnicity: unknown; requested but not provided.Date of event: unknown, not provided, but the best estimate date is between oct 8, 2009 and aug 8, 2022.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed and no non-conformance report (nc) was found as part of this manufacturing records review.The product was manufactured and released according to specification.The search revealed that no other complaints for this production order number have been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.Attempts were made to obtain the missing information; however, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient required an explant of the intraocular lens (iol) from their left eye (os) in a secondary surgery.The reason for the explant was not specified and the patient outcome was not provided.No further information available.
Additional Manufacturer Narrative
Additional information was received with the product return.The intraocular lens (iol) was explanted due to displacement.The following sections have been updated accordingly: section h6: health effect - clinical code: 4581 device decentered or dislocated or tilted.Subluxated or wrong position : device dislocation.Section h6: medical device problem code: 2923 instability of device after implantation.Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 9/13/2022.Section h3: device evaluated by manufacturer¿ yes.Device evaluation:.The complaint lens was received inside of a different serial numbers lens case and folding carton (sn:(b)(6).Visual inspection under magnification revealed that the complaint lens was received cut in half and with both haptics bent.The lens was cleaned and no further issues could be identified.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue was not confirmed.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.All pertinent information available to johnson and 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: 15332779
• Report Number: 3012236936-2022-02242
• Device Sequence Number: 15192677
• Product Code: HQL
• UDI-Device Identifier: 05050474514072
• UDI-Public: (01)05050474514072
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• 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): 11/03/2022

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 Expiration Date: 07/31/2011
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00035
• 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: 08/09/2022
• Supplement Date Received by Manufacturer: 10/29/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2006
• 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: 72 YR
• Patient Sex: Male