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

Model Number ZCT525

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Visual Impairment (2138); No Code Available (3191)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Date of event: unknown, information not provided, but the best estimate date is during (b)(6) 2019.If implanted, give date: unknown, information not provided.Reporter phone #: (b)(6).(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported lens calculation was performed on the johnson & johnson (j&j) platform with indication for lithium zct450 diopter 23.0 intraocular lens (iol).Barrets calculator indicated a zct300 23.5 diopter iol, but the surgeon followed j&j calculator, and the patient¿s postoperative visual acuity is +1 -1.75(80).The doctor proposes an explant.User result says postoperative dissatisfaction with low acute vision.Additional information confirmed lens explant/exchanged for a model zct525 23.0 diopter lens based on the replacement lens serial number provided.Exchange was performed requiring incision enlargement without suturing.In the preoperative period, refraction was +1.00 -1.75 (80) with complaints, there was an inversion of the original axis due to the placement of a lens with greater astigmatism.Patient evolved well with refreshment (replacement lens) +0.25 -0.75 (170) with 20/15p vision.Redo calculations by barret calculator was successful with the original lens that was indicated by the (j&j) calculator.No further information provided.

Manufacturer Narrative

Device evaluation: product testing could not be performed because the product was not returned.The complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaints were received for this production order number.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.H3 other text : placeholder.

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 nr-(b)(4) and capa-010215.

• Brand Name: TECNIS
• Type of Device: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9532249
• MDR Text Key: 182703251
• Report Number: 9614546-2019-01136
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474589537
• UDI-Public: (01)05050474589537(17)230611
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2023
• Device Model Number: ZCT525
• Device Catalogue Number: ZCT5250230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention