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

Model Number	AAB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	11/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens aab00 +11.5 diopter was implanted in the patient left eye on (b)(6) 2017.At the one (1) week post-op visit, the patient was complaining of blurry vision.Reportedly, the lens was explanted on (b)(6) 2018 and replaced with a z9002 lens +11.0 diopter.The incision was enlarged, but no vitrectomy was performed and no sutures were used.The patient was reported doing fine post-surgery.No additional information provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 7/10/2018.Device returned to manufacturer? yes.Device evaluation: the reported lens returned cut in three (3) pieces.The condition observed in the lens is consistent with a unit that has been cut due to ¿iol removal process or explant¿.Visual inspection using magnification was performed.Loose particles compatibles with handling the lens out of the sterile environment were observed on the lens optic body.During sample evaluation the pieces of lens returned were observed clear as expected in the acrylic monofocal iols.No blurry, hazy, obscured, and/or unclear condition were detected on the return.The reported issue could not be verified.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search revealed that no additional complaints were received for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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 & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7556824
• Report Number: 2648035-2018-00804
• Device Sequence Number: 11391026
• Product Code: HQL
• UDI-Device Identifier: 05050474548497
• UDI-Public: (01)05050474548497(17)190609
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 06/09/2019
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 08/30/2018
• 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
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005