MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. SENSAR; MONOFOCAL IOLS

Model Number	AR40E
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was inserted and removed.(b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the haptic of the intraocular lens (iol) kinked during insertion into the patient's operative eye.Reportedly, the iol was removed and replaced in the same procedure.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes, returned to manufacturer on: 11/26/2018, device returned to manufacturer: yes.Device evaluation: the complaint unit was received.Visual inspection using microscope magnification was performed.The lens was received with a damaged haptic.Viscoelastic residue was detected on the lens.The lens was also damaged and the condition of returned lens is consistent with a lens that has been explanted/removed.The reported issue was verified, but it could not be determined if the condition of returned lens is related to the manufacturing process as the reported lens was handled in a surgical procedure.Based on the product return evaluation, a product quality deficiency nor a product malfunction could be determined.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaint has been received for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7854800
• Report Number: 2648035-2018-01221
• Device Sequence Number: 1431482
• Product Code: HQL
• UDI-Device Identifier: 05050474514065
• UDI-Public: (01)05050474514065(17)220602
• Combination Product (Y/N): Y
• Initial Reporter Country: SG
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2020
• Report Date (Section F): 01/01/2005

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: 06/02/2022
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 12/11/2018; 10/25/2020
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 01/08/2019; 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005