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

Model Number	AR40E
Medical Device Problem Codes	Break (1069); Failure to Fold (1255)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant date: not applicable, as lens was not implanted.Explant date: not applicable, as lens was not explanted.Initial reporter telephone number: (b)(6).An attempt has been made to obtain missing information; 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 that there was folding issue with the leading haptic.Implantation was halted (delayed) because intraocular lens (iol) retracted from the eye but iol was not fully implanted.The iol checked under microscope and leading haptic out of shape.
Additional Manufacturer Narrative
Section d.Device available for evaluation? yes returned to manufacturer on: 4/26/2021 section h3.Device evaluated by manufacturer? yes device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, which is consistent with a lens that was handled during insertion.The lens was cleaned and haptic damage and lens damage were observed, which can both be attributed to handling and receiving the lens crushed in the lens insert and cannot be confirmed to be related to manufacturing.No product deficiency could be identified.Manufacturing record evaluation: based on the manufacturing records review, and historical complaint review, there is no indication of a product malfunction or product quality deficiency.No nonconformity report, documentation or labeling changes, and escalations are required.A search revealed that no other complaints were received from this production order.Conclusion: based on the information obtained, product malfunction and product deficiency cannot be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: section h6: as part of an internal review of our mdrs it was identified that the impact code 2199 no health consequences or impact provided on the initial report needs to be corrected.Impact code 2199 no longer applicable.The correct impact code is 4632 delay in treatment.The following section has been updated accordingly: section h6: health effect - impact code: 4632 delay in treatment.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 ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 11610214
• Report Number: 2648035-2021-07494
• Device Sequence Number: 3898522
• Product Code: HQL
• UDI-Device Identifier: 05050474501867
• UDI-Public: (01)05050474501867(17)230321
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2022

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: 03/21/2023
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 05/03/2021; 08/28/2022
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 05/29/2021; 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2018
• 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: Female