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

Model Number	AAB00
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: difficult to use, haptic damaged 1, haptic damaged 2, cosmetic issues 1, lens damaged 1.Serial numbers of suspect products: (b)(4).2 investigations were completed and 3 are pending from the period.From the 2 investigations: 2 products were not returned.In all the investigations 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 file.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 5 malfunction events.The events were related to lens damaged.There were no patient injuries reported associated to the events.No further information provided.
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 (b)(4) and capa (b)(4).
Additional Manufacturer Narrative
Additional information: there were 3 investigations completed during this period.Breakdown of 3 investigations with respective lot numbers are as follows: 2339371905, no product returned; 3079681907, no product returned; 5721511904, haptic damaged, iol torn.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.

• 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: 9644794
• Report Number: 2648035-2020-00084
• Device Sequence Number: 2460698
• Product Code: HQL
• UDI-Device Identifier: 05050474548688
• UDI-Public: (01)05050474548688
• Combination Product (Y/N): Y
• PMA/510(K) Number: P980040
• Number of Events Summarized: 5
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: AAB00
• Device Catalogue Number: AAB0000210
• 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; 10/25/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 04/23/2020; 10/28/2020
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005