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

Model Number	AR40E
Medical Device Problem Codes	Break (1069); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown.Sex/gender: unknown.If implanted; give date: not applicable as the lens was inserted and removed.If explanted; give date: not applicable as the lens was inserted and removed.Phone number (b)(6).The intraocular lens (iol) is not returning for evaluation as it was destroyed by the customer; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was initially reported that the haptic of the iol (intraocular lens) was wedged-in during the loading process and was observed kinked/bent when inserted into the patient's eye.Reportedly, the lens was removed and a new lens was implanted without issues during the initial procedure.Through follow up it was learned that the incision was minimally enlarged to allow the removal of the lens but did not require sutures or vitrectomy.The patient and the surgeon were reported being happy with the outcome.The account commented that the lens was destroyed at the customer site.No additional information was provided.
Additional Manufacturer Narrative
Inadvertently the date entered into "date received by manufacturer" in the initial report 7th march 2019 was incorrect.The correct date that should have been entered is 18th march 2019.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 (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: 8491161
• Report Number: 2648035-2019-00436
• Device Sequence Number: 13837398
• Product Code: HQL
• UDI-Device Identifier: 05050474502185
• UDI-Public: (01)05050474502185(17)230626
• Combination Product (Y/N): Y
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2023
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 05/01/2019; 10/25/2020
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 05/29/2019; 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMERALDC30 CARTRIDGE, LOT CE00074; EMERALDC30 CARTRIDGE, LOT CE00074
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005