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

Model Number	AR40M
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable, as lens was not implanted.Device evaluation: the complaint lens was received in its original lens case.The original folding carton, patient stickers, patient id card, implant notification card, and dfu were received as well.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, a bent haptic, and that the lens was received cut in half (but not separated), which is consistent with a lens that was handled during explant or removal and replacement.Based on the return condition of the lens, no further product evaluation could be performed.¿dc-foreign material ¿ loose¿ could not be confirmed, because per the initial report the foreign material was observed ¿during handling but prior to insertion¿, however the return condition of the lens suggests that the lens was handled with viscoelastic residue and then inserted and eventually explanted or removed and replaced, in which the foreign material may have been lost during handling and not returned with the lens for evaluation.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaint was received from this production order.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
It was reported that there was debris on the lens and this was observed during handling and prior to insertion into to the eye.No further information available.

• 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: 11385413
• Report Number: 2648035-2021-00030
• Device Sequence Number: 4162732
• Product Code: HQL
• UDI-Device Identifier: 05050474514294
• UDI-Public: (01)05050474514294(17)230904
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2021

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: Health Professional
• Device Expiration Date: 09/04/2023
• Device Model Number: AR40M
• Device Catalogue Number: AR40MN0075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1