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

Model Number	ZA9003
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Corneal Edema (1791); Hemorrhage/Blood Loss/Bleeding (1888); Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is from (b)(6) 2018.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient's left eye had an anterior and small posterior capsular tear, therefore the za9003 intraocular lens (iol) was implanted into the sulcus on (b)(6) 2018.Reportedly, the lens was explanted on (b)(6) 2018 as the iol was dislocated vertically (anterior & posterior) with iris hemorrhage.The replacement lens was a competitor lens.There was no incision enlargement and no vitrectomy was performed.The patient had mild corneal edema with visual acuity of 20/50 one week post-op.No additional information provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 7/10/2018.Device returned to manufacturer? yes.The sample was returned to the manufacturer.The lens is cut in two pieces, approximately half, the cut observed could be related to the removal process described on the initial report.Both haptics are bent and one is detached.The reported issue could not be verified.The manufacturing records for the device were reviewed.The product was manufactured and released according to specification.The search in complaint history revealed no other investigation request has been received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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 and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7581573
• Report Number: 2648035-2018-00844
• Device Sequence Number: 2355048
• Product Code: HQL
• UDI-Device Identifier: 05050474528871
• UDI-Public: (01)05050474528871(17)220204
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2018
• 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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/04/2022
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030130
• 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: 05/11/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 08/15/2018
• 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: 68 YR
• Date Report Sent to FDA: 01/01/2005