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

Model Number ZCB00

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Blurred Vision (2137); Vitrectomy (2643); No Code Available (3191)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

Additional information: (b)(4).Device evaluation: product testing could not be performed because the product was not returned as it was discarded.A product quality deficiency could not be confirmed.The reported issue was not 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 revealed that no other complaints for this production order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye).The lens was explanted due to complaints of day one (01) blurry with double vision and replaced with a non-johnson & johnson surgical vision lens.The iol was also dislocated, decentered 2-3mm temporally, and situated in the anterior capsule.Pars plana vitrectomy and limbal relaxation incisions were performed.There was no incision enlargement and no patient injury.Patient outcome was reported as: visual acuity (va) is terrific, double vision and blurry vision has been resolved.No additional information was provided.

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-0148919 and capa-010215.

• Brand Name: TECNIS 1-PIECE
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 10382910
• MDR Text Key: 202179785
• Report Number: 2648035-2020-00596
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531789
• UDI-Public: (01)05050474531789(17)230918
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/29/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2023
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000235
• 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
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR