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

Model Number	Z9002
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: unknown, not provided.If implanted; give date: not applicable as the lens was inserted and removed.If explanted; give date: not applicable as the lens was inserted and removed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (model z9002 +26.0 diopter) did not unfold properly into the patient's operative eye (right).Reportedly, the lens was removed.The incision was not enlarged.The procedure was completed using a backup lens of the same model and diopter.The patient was reported as recovered.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 05/17/2018.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection showed dry residue of viscoelastic on the lens optic and haptics.Both lens haptics were observed in good shape and form.No damages were detected.The condition observed on the lens was consistent with a unit that was handled and prepared for use.No manufacturing defects were detected on the returned lens.The customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional investigation requests for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (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 CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7509442
• Report Number: 2648035-2018-00698
• Device Sequence Number: 1529255
• Product Code: HQL
• UDI-Device Identifier: 05050474530812
• UDI-Public: (01)05050474530812(17)170914
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2018

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: Physician
• Device Expiration Date: 09/14/2017
• Device Model Number: Z9002
• Device Catalogue Number: Z900200260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1