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

Model Number	PCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	04/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a pcb00 31.0 diopter intraocular lens (iol) was implanted in the patient's right (od) eye on (b)(6) 2019.At day 1 post-op, patient reported to have experienced blurry vision and residual astigmatism.The lens was later explanted on (b)(6)2019 without complications or further surgical intervention.The replacement lens is a zxt150 30.5 diopter iol.Reportedly, patient noticed an improvement with her vision.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 12/24/2019.Device evaluation: the product was returned to the manufacturing site.Visual inspection using magnification was performed to the returned sample: lens returned cut in two pieces.Loose fibers/particles were observed on lens pieces related the handling of the unit out of a sterile environment.Residues of lubricant material and material looks like body fluids were also observed on lens pieces.The condition in which the sample returned is consistent with a lens that was implanted and explanted.Based on the analyzed of the returned; there is no indication of a product quality deficiency.The complaint issue reported could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed no additional investigation requests for this production order number.Conclusion: as a result of the investigation, there is no indication of a quality product deficiency and the reported issue could not be verified.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(b)(4).

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• 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: 9441142
• Report Number: 2648035-2019-01300
• Device Sequence Number: 2436329
• Product Code: HQL
• UDI-Device Identifier: 05050474558489
• UDI-Public: (01)05050474558489(17)201130
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 11/30/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 01/09/2020; 10/25/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 01/10/2020; 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
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005