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

Model Number ZA9003

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

Patient gender: unknown as information was not provided.If implanted, give date: not applicable, as lens was removed/ replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/ replaced in the initial surgery.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

After za9003 20.0 diopter intraocular lens (iol) was placed in the patient¿s operative eye customer account reported the za9003 lens was removed, during the same procedure, as the eye was pushing the iol out and replaced with a non-johnson & johnson surgical vision lens.It was also reported there was no patient injury however the incision was enlarged, suture(s) were required.Patient outcome post-op was reported as good.No further information is available.No additional information was provided to johnson & johnson surgical vision.

Manufacturer Narrative

Device evaluation: no lens returned.Only carton box, lens case/insert, and dfu (directions for use) were returned.However, there was no failure against the lens reported.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 additional 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.

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
• 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: 9748861
• MDR Text Key: 180784821
• Report Number: 2648035-2020-00176
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474529014
• UDI-Public: (01)05050474529014(17)241203
• Combination Product (y/n): Y
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/02/2020

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 Model Number: ZA9003
• Device Catalogue Number: ZA90030200
• 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: 01/30/2020
• Initial Date FDA Received: 02/25/2020
• Supplement Dates Manufacturer Received: 03/16/2020; 10/25/2020
• Supplement Dates FDA Received: 04/09/2020; 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR