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

Model Number	AR40M
Medical Device Problem Codes	Break (1069); Device Handling Problem (3265)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.(b)(4).Device evaluation: the device was not returned at the manufacturing site as it was discarded; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no other complaint for this production order number has been received.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.
Event or Problem Description
It was reported that an intraocular lens (iol) was fully inserted and removed during the same-day procedure due to a kinked haptic.The lens was discarded.Further information was reported that the technician loaded the lens improperly and bent the haptic.After insertion, the haptic would not hold in place, therefore, a replacement lens was needed.Another johnson & johnson lens (same model and diopter) was implanted as a replacement.The incision was enlarged and one suture was placed in the eye.There was no patient injury.No additional information was provided.

• 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: 10526037
• Report Number: 2648035-2020-00677
• Device Sequence Number: 3575532
• Product Code: HQL
• UDI-Device Identifier: 05050474514232
• UDI-Public: (01)05050474514232(17)241031
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: AR40M
• Device Catalogue Number: AR40MN0015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/12/2020
• 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
• Patient Age: 67 YR