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

Model Number	AR40M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable, as lens was not implanted.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 an ar40m intraocular lens (iol) was noticed to have a kinked haptic when advancing into the eye.There was patient contact with the iol but no intervention was required.The procedure was completed successfully with another iol of the same model and diopter.The patient appeared alright when discharged.No additional information was provided.
Additional Manufacturer Narrative
Additional information received reported patient gender is male.The name of the surgeon was reported as (b)(6).As a result the following fields have been updated: patient gender: male, initial reporter name and address: first name: (b)(6), middle name: (b)(6), last name: (b)(6).Initial reporter health professional: yes, initial reporter occupation: physician.Device available for evaluation: yes, returned to manufacturer on: 03/27/2019.Device returned to manufacturer: yes.Device evaluation: sample was received on 03/27/2019 at the investigation site in its original package.Visual inspection was performed on the returned sample.Loose fibers/particles were observed on lens related the handling of the unit out of a sterile environment.Residues of viscoelastic material was also observed on lens.Part of the lens was observed broken.Both haptics was observed detached.The detached haptic pieces were not returned.The condition in which the sample returned is consistent with a lens that was implanted and removed.The complaint issue reported as haptic damaged was not verified.However, haptic detached was identified on lens returned.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 no additional investigation requested for this production order number.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 and the reported issue could not be verified.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 (b)(4) and capa-010215.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8429631
• Report Number: 2648035-2019-00354
• Device Sequence Number: 2765407
• Product Code: HQL
• UDI-Device Identifier: 05050474501836
• UDI-Public: (01)05050474501836(17)230317
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020
• 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: 03/17/2023
• Device Model Number: AR40M
• Device Catalogue Number: AR40M00010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 03/18/2019; 10/25/2020
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 04/09/2019; 11/11/2020
• 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