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

Model Number	ZA9003
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant and explant dates: if implanted or explanted; give date: n/a (not applicable).The intraocular lens was not implanted.Initial reporter's phone: - (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that za900 intraocular lens (iol) ''spoiled'' or marked in a manner that was not implantable.The alleged issue was noticed during handling, but prior to insertion into the eye.Iol is not used as there was no patient involvement and/or injury reported.Product will be returned.No additional information provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 1/8/2019.Device returned to manufacturer: yes.Device evaluation: the za9003 lens was received in the original folding carton.Visual inspection using magnification was performed.The lens was observed with one lens haptic distorted/bent.The other haptic was observed in good form and shape.No defects such as ¿lens edge spoiled or marked¿ were observed in the returned sample.No product deficiency was identified.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 complaint has been received for this production order.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 & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f 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-010215.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7822964
• Report Number: 2648035-2018-01165
• Device Sequence Number: 1116900
• Product Code: HQL
• UDI-Device Identifier: 05050474528949
• UDI-Public: (01)05050474528949(17)230227
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2023
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 02/04/2019; 10/25/2020
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 02/28/2019; 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005