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 1 event is as follows: haptic detached 1.Serial number of the suspect product: (b)(4).1 investigation was completed and 0 investigations are pending from this period.Breakdown of 1 completed investigation: (b)(4).Lens cut, haptic detached.The investigation concluded that the product met manufacturing release criteria.Device evaluation: the complaint lens was received inside the original lens case.The original folding carton and customer notes were received as well.Visual inspection under magnification revealed what appeared to be dried blood and viscoelastic residue on the optic body and haptic (only one detached haptic was received), and that the lens was received cut in half (only one half of the lens was received), and an additional cut was made on the lens without separating the lens, which is consistent with a lens that was handled during removal and replacement.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that one additional complaint for this order number has been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
This report summarizes 1 malfunction events.The events were related to lens damage.There were no patient injuries reported associated to the events.
Additional Manufacturer Narrative
Correction: this correction mdr, is to address inaccurate or missing information in section h6 evaluation codes reported in the initial submission.Method: was left blank and should have been 10, 3331, 4109; results: was left blank and should have been 213, 114; conclusion: stated, 11 and should have been 67.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: 10753137
• Report Number: 2648035-2020-00786
• Device Sequence Number: 16973705
• 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: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2021

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
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 01/31/2021
• Patient Sequence Number: 1