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

Model Number	AR40E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Explant date: if explanted, give date: unknown/not provided.(b)(6).(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that on (b)(6) 2019, after the intraocular lens (iol), model ar40e 12.0 diopter was implanted using the out the bag (extra capsular fixation) procedure, the lens was not stable in the eye.It was indicated that the lens was explanted and replaced with a competitor's lens.There was no patient injury.No additional information was reported.
Additional Manufacturer Narrative
Device available for evaluation; returned to manufacturer on: 9/6/2019.Device evaluation: the device was received in a bag at the manufacturing site for investigation.The lens was observed under microscope and it was received cut.Typical condition of a lens that has been removed.The haptics were observed positioned.This complaint is about a situation during the surgical process and could not be verified.A product quality deficiency was not identified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaint was received for this production order.Conclusion: based on the investigation results, there is no indication of a product quality deficiency.All pertinent information available to johnson and 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 & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8814799
• Report Number: 2648035-2019-00747
• Device Sequence Number: 343201
• Product Code: HQL
• UDI-Device Identifier: 05050474501942
• UDI-Public: (01)05050474501942(17)201209
• Combination Product (Y/N): Y
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020
• 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: 12/09/2020
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 09/17/2019; 10/25/2020
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 10/10/2019; 11/13/2020
• 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
• Date Report Sent to FDA: 01/01/2005