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

Model Number	AR40M
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.The device was not returned; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, and complaint trending 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 reported an intraocular lens (iol) was removed from the patient's right (od) eye upon insertion because the surgeon noticed a scratch on the lens.The replacement lens is the same model and diopter.At exchange, incision was enlarged along with sutures were used.The current patient status was reported as left normally.The customer also indicated that the lens was cut into pieces and not being sent back for analysis.No further information provided.
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: 9982610
• Report Number: 2648035-2020-00365
• Device Sequence Number: 4355693
• Product Code: HQL
• UDI-Device Identifier: 05050474514089
• UDI-Public: (01)05050474514089(17)230608
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/30/2020
• 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: 06/08/2023
• Device Model Number: AR40M
• Device Catalogue Number: AR40E00045
• 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: 03/31/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 10/30/2020
• 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: 63 YR
• Date Report Sent to FDA: 01/01/2005