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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date unknown, not provide.Best estimate is (b)(6) 2020.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted due to blurry vision.It was replaced with same model lower diopter power (17.5).There was no incision enlargement, no vitrectomy and no sutures done.It was stated that the patient is fine post-op.No other information was provided.
Additional Manufacturer Narrative
Section d10.Device available for evaluation?: yes.Returned to manufacturer on: 9/21/2020.Section h3.Device returned to manufacturer?: yes.Device evaluation: the complaint lens was received in a specimen cup.A completed jjsv shipping guide was received as well.Visual inspection under magnification revealed what appeared to be dried blood and viscoelastic residue on the optic body and haptics and that the lens was returned cut in pieces (with missing pieces), which is consistent with a lens handled during explant.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed 2 complaint folders which were coded for ¿improperly loaded¿, not related to this reported event, and therefore, no further escalations are required.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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10589515
• Report Number: 2648035-2020-00712
• Device Sequence Number: 1167989
• Product Code: HQL
• UDI-Device Identifier: 05050474548633
• UDI-Public: (01)05050474548633(17)210121
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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: Health Professional
• Device Expiration Date: 01/21/2021
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 10/12/2020
• 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