MAUDE Adverse Event Report: JOHNSON & 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	Blurred Vision (2137); Visual Disturbances (2140); No Code Available (3191)
Date of Event	07/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If explanted; give date: not applicable lens remains implanted.(b)(4).Device evaluation: product evaluation was not preformed because per the initial report the lens is still implanted in the patient's eye.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related this production order (po) was performed.No other complaints have been received for this po number.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: 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.
Event or Problem Description
It was reported that after implantation of a model zcb00 intraocular lens (iol), patient experienced symptoms of blurry vision, milky vision and color changes, like white dogs are purple and black dogs are dark blue.When she was first implanted, she felt like there was bright light all the time and needed to use yellow tinted sunglasses.When the sun is out now the she feels like she is in uv light (purple).When reading she finds the text pale gray, like she is wearing dirty glasses.The surgeon has told her that there is a slight posterior capsule opacification (pco) but not much.The patient thinks there is something wrong with the implant.Additional information states the surgeon could tell us that the patient already has problems with the operated eye that has nothing to do with the implant, there is also quite a lot of pco that he will not remove yet if he needs to explant the iol.Further information provided, patient has had good visual acuity (va) 20/20 from the day after surgery but complains of poor contrast sensitivity (which has not been confirmed in adequate testing), a changed sense of color perception with a dominance of blue (color testing though normal).In a slit lamp view, the iol is perfectly normal.All information available is provided.
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 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9550349
• Report Number: 2648035-2020-00012
• Device Sequence Number: 2993636
• Product Code: HQL
• UDI-Device Identifier: 05050474531574
• UDI-Public: (01)05050474531574(17)211012
• Combination Product (Y/N): Y
• Initial Reporter Country: SE
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/12/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 11/05/2020
• 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
• Date Report Sent to FDA: 01/01/2005