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

Model Number ZCT375

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

Patient Problems Therapeutic Effects, Unexpected (2099); No Code Available (3191)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation: product evaluation cannot be performed as per the initial report, the lens is not available for return.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the device were reviewed.Results revealed the product was manufactured and released according to specifications.A search of complaints was conducted.The search revealed that no other complaints have been received for this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a model zct375 model intraocular lens(iol) was explanted from patient's left eye in a secondary surgical procedure because of residual astigmatism post cataract surgery and reduced distance vision.Additional information was received stating that no medical/surgical interventions such as vitrectomy, incision enlargement or sutures were required.The replacement lens is a different model zct225, but same diopter lens.The patient was doing fine at the time of discharge.Patient/user outcome: visual acuity pre-op (pre-initial implant): best corrected visual acuity (bcva) 20/40-1; visual acuity post-op (post-initial implant):20/40-1; visual acuity post-op (post-replacement):20/25-2.No further information provided.

• 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
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; road 402 north, km 4.2; anasco industrial park; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 11017434
• MDR Text Key: 222017702
• Report Number: 2648035-2020-00936
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474588394
• UDI-Public: (01)05050474588394(17)250114
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ZCT375
• Device Catalogue Number: ZCT3750250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR