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

Model Number	AR40E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens was removed/replaced in the initial surgery.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson vision has been submitted.
Event or Problem Description
It was reported that the monofocal intraocular lens (model ar40e, +24.5 diopter) haptic tore while inserting into the eye.The lens was removed and replaced in the same procedure.Reportedly a vitrectomy, incision enlargement and sutures were required.No further information provided.
Additional Manufacturer Narrative
Additional information was provided and has been updated accordingly: a vitrectomy, an incision enlargement, along with sutures were used.Patient is doing great.No adverse effects.Age/date of birth: (b)(6), gender/sex: female, device available for evaluation: yes, returned to manufacturer on: 10/11/2018.Complaint reporter(s): dr.(b)(6), health professional(s): yes, occupation: physician(s).Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The lens was received inside the lens case.The lens was observed under microscope with viscoelastic residue.One haptic was observed positioned and the other was observed detached and bent.The haptic drill hole of the detached haptic was measured to addressed the complaint and was found within acceptable results.The complaint haptic damaged was not verified in the returned lens sample; however, a haptic detached condition was observed.This observation could not be related to the manufacturing process and could be related to the handling process.No product quality deficiency was identified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed one other complaint under this production order; but was not related to this reported complaint.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 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-(b)(4).

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC; santa ana CA
• MDR Report Key: 7976210
• Report Number: 2648035-2018-01341
• Device Sequence Number: 19146298
• Product Code: HQL
• UDI-Device Identifier: 05050474502192
• UDI-Public: (01)05050474502192(17)210416
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 11/03/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/16/2021
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 10/24/2018; 10/25/2020
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/16/2018; 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Date Report Sent to FDA: 01/01/2005