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: breakdown of 7 events is as follows: haptic damaged, 1; inserter problem,iol torn, 1; iol torn, 1; lens damaged, 4.Lot number of suspect product: (b)(4), 1; (b)(4), 1; (b)(4), 1; (b)(4), 1; (b)(4), 1; (b)(4), 1; (b)(4), 1.Additional manufacturing site address for serial number (b)(4) (only) is as follows: (b)(4).3 investigations were completed and 4 are pending.Breakdown of 3 completed investigations: (b)(4), no product returned; (b)(4), no product returned; (b)(4), no product returned.The investigation concluded that the product met manufacturing release criteria.A review of the records related to the device including complaint trend and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained then a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
This report summarizes 7 malfunction events.The events were related to lens damage.There were no patient injuries reported associated to the events.
Additional Manufacturer Narrative
Additional information: there are 5 investigations completed during this period.Breakdown of 5 investigations with respective lot/serial numbers are as follows: (b)(4) no issues identified (b)(4) iol torn (b)(4) damaged / broken, haptic damaged, haptic stuck to optic (b)(4) no product returned (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
Correction: in the initial report it was indicated that there were 7 events however, the correct number is 6 since during this quarter additional information was received indicating that one of the products with serial number 4775082003 was inadvertently reported under lens damage.However on further review this serial number was associated with malfunction foreign material in the eye and will be reported as 30 day malfunction instead under a separate report.Also, the breakdown of events is now for 6 events and total number of lens damage is 3 instead of 4.Revised breakdown for the events would be as follows: haptic damaged 1 inserter problem, iol torn 1 iol torn 1 lens damaged 3 no further information will be provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.
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.

• 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: 10296429
• Report Number: 2648035-2020-00513
• Device Sequence Number: 3032276
• 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: 7
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/16/2020
• 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; 01/14/2005; 10/25/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 07/22/2020; 10/29/2020; 11/16/2020
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005