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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: breakdown of the 4 events of is as follows: haptic damaged 2, haptic detached 1, damaged / broken 1.Serial numbers of suspect products: (b)(4).3 investigation were completed, and 1 investigation is pending from the period.Out of 3 investigations, products were not returned.In the investigation it was concluded that products met manufacturing release criteria and no product deficiency was identified.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.That was received during the time period that covers this voluntary malfunction summary report has been submitted.
Event or Problem Description
This report summarizes 4 malfunction events.The events were related to lens damaged.There were no patient injuries reported associated to the events.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f and g.4 date 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.
Additional Manufacturer Narrative
Additional information: there are 2 investigations completed during this period.Breakdown of 2 investigations with respective lot/serial numbers are as follows: (b)(4) lens cut, haptic damaged (b)(4) no product returned the investigations concluded that product met manufacturing release criteria and no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.That was received during the time period that covers this voluntary malfunction summary report has been submitted.
Additional Manufacturer Narrative
In the initial report it was indicated that there were 4 events during this period however, 1 event was inadvertently not included.The correct number of events for this period is 5.The additional serial number that was missed is (b)(6).Haptic damaged was reported for this product.Investigation for this serial number is pending from this period.All pertinent information available to johnson & johnson surgical vision, inc.That was received during the time period that covers this voluntary malfunction summary report has been submitted.

• 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: 10002944
• Report Number: 2648035-2020-00392
• Device Sequence Number: 16911799
• Product Code: HQL
• UDI-Device Identifier: 05050474514249
• UDI-Public: (01)05050474514249
• Combination Product (Y/N): Y
• PMA/510(K) Number: P980040
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/28/2020
• 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: No Information
• Device Model Number: AR40M
• Device Catalogue Number: AR40MN0025
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/14/2005
• Supplement Date Received by Manufacturer: 01/14/2005; 01/14/2005; 10/25/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 04/30/2020; 07/22/2020; 10/28/2020
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005