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

Model Number	AR40M
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The intraocular lens was removed and replaced during the same procedure.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was folded and inserted in the anterior chamber of the eye but it would not unfold, so it had to be removed.The incision was enlarged.No additional information was provided to johnson and johnson surgical vision, inc.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 5/23/2018.Device returned to manufacturer? yes.Device evaluation: sample was return to the manufacturer: only returned lens insert/case was returned in a plastic bag.The reported complaint could not be verified.Product deficiency could not be determined.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.There was no discrepancy found during the review.A search revealed no additional investigations requested for this production order.Labeling review: the dfu was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7482189
• Report Number: 2648035-2018-00647
• Device Sequence Number: 16513100
• Product Code: HQL
• UDI-Device Identifier: 05050474501836
• UDI-Public: (01)05050474501836(17)210511
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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: Physician
• Device Expiration Date: 05/11/2021
• Device Model Number: AR40M
• Device Catalogue Number: AR40M00010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 06/26/2018
• 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