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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date of unknown is not provided.Best estimate is between (b)(6) 2018-(b)(6) 2018.(b)(6).(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was planned with the target refraction -1.5d.Post implantation, the patient had a sub-refraction of -2.25d and is unhappy.An explant/exchange was performed in the left eye.There was no incision enlargement, sutures or vitrectomy required.The replacement lens was another lens of the same model but a lower diopter (9.0).The patient is reported to be happy with the visual outcome after the explant/exchange procedure.A follow up is planned for the (b)(6) 2018.No additional information was provided to johnson and johnson surgical vision, inc.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 05/30/2018.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection under the microscope showed lubricant residue and lose particles on the lens surface.No damage/defect was observed on lens.There was no quality issue identified.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 complaints 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 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7517370
• Report Number: 2648035-2018-00713
• Device Sequence Number: 1704052
• Product Code: HQL
• UDI-Device Identifier: 05050474531512
• UDI-Public: (01)05050474531512(17)200318
• Combination Product (Y/N): Y
• PMA/510(K) Number: P980040
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018
• 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?: No
• Operator of Device: Physician
• Device Expiration Date: 03/18/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 07/10/2018
• 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
• Date Report Sent to FDA: 01/01/2005