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

Model Number	AAB00
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter phone number: (b)(6).(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a mark on an aab00 23.5 diopter intraocular lens (iol) was noticed by the doctor after the lens was inserted into the eye.An incision enlargement was performed to extract the lens and another sensar 1-piece lens was implanted.The incision was then closed with a suture.Reportedly, there was no significant time added to the surgery.There was no vitrectomy performed.Also, there was no patient injury and the patient recovered with no impact.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 03/14/2018.Device returned to manufacturer? yes.Device evaluation: the sample was returned to the manufacturer.Residues of ophthalmic viscoelastic devices (ovd) were observed on the lens surface.A scratch was observed on the optic zone.Since the lens was prepared and surgically inserted to the patient's eye, it could not be determined if the observed mark is related to the manufacturing process.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 that no other 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: 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 & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7345868
• Report Number: 2648035-2018-00393
• Device Sequence Number: 709183
• Product Code: HQL
• UDI-Device Identifier: 05050474548732
• UDI-Public: (01)05050474548732(17)210805
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2018

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: 08/05/2021
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 04/16/2018
• 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