MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zcb00 15.5 diopter intraocular lens (iol) was noticed torn after being implanted in the patient's right eye (od).The lens was therefore removed and an incision enlargement was made with one suture being used.There was no patient injury and the patient is doing great post-operatively.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 03/08/2018.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection using microscope magnification was performed.The lens returned cut in two parts.Residue of viscoelastic was detected on both section of the lens optic and including the haptics.The lens condition observed is consistent with a unit that has been cut during surgical process.The reported issue was verified.However, based on the evidence observed the reported lens has not been affected by the manufacturing process.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints were received for this production order number.Labeling review: 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 & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7319373
• Report Number: 2648035-2018-00341
• Device Sequence Number: 10789214
• Product Code: HQL
• UDI-Device Identifier: 05050474531628
• UDI-Public: (01)05050474531628(17)190820
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2018

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: 08/20/2019
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 03/21/2018
• 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: 69 YR