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

Model Number	Z9002
Medical Device Problem Codes	Positioning Failure (1158); Failure to Align (2522)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: unknown/not provided.If explanted; give date: unknown/not provided.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that surgeon was concerned of z9002 monofocal intraocular lens (iol) would not center in the right eye (od) due to patient's anatomy.The doctor opted to remove and replace with non-jnjsv (johnson & johnson surgical vision) product.It was noted that incision enlargement was performed to remove the lens.However, there was no patient injury as the patient is doing fine post-surgery.Product is expected to be returned.No additional information provided.
Additional Manufacturer Narrative
Corrected data: in the initial mdr 2648035-2018-01222 the product code was incorrectly entered as hno.The correct code is hql.(b)(4).Additional info: device available for evaluation? yes.Returned to manufacturer on: 09/28/2018.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 loose particles and lubricant material residue on the lens surface.The haptics were distorted, which could be related to the handling of the lens during the removal process.The customer's reported complaint was verified, however, there was no indication of product quality deficiency.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints have been 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: in the supplemental mdr 2648035-2018-01222, the conclusion code was inadvertently not populated.The field was updated accordingly.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-(b)(4).

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7856188
• Report Number: 2648035-2018-01222
• Device Sequence Number: 1369185
• Product Code: HQL
• UDI-Device Identifier: 05050474530768
• UDI-Public: (01)05050474530768(17)220324
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• 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,Followup,Followup
• Report Date (Section B): 11/03/2020
• 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: Health Professional
• Device Expiration Date: 03/24/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 10/01/2018; 10/30/2018; 10/25/2020
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 10/28/2018; 11/05/2018; 11/03/2020
• 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: 70 YR
• Date Report Sent to FDA: 01/01/2005