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

Model Number ZA9003

Device Problem Unintended Movement (3026)

Patient Problems Hemorrhage/Bleeding (1888); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown as information was not provided.The best estimate date is between (b)(6) 2020 and (b)(6) 2020.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported za9003 20.5 diopter intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye) on (b)(6) 2020.During retinopathy procedure the za9003 20.5 diopter lens was explanted on (b)(6) 2020 due to vitreous hemorrhage, bleeding and dislocated iol and replaced with another za9003 20.5 diopter lens.It was reported there was no retina tear or detachment.No additional information was provided to johnson & johnson surgical vision.

Manufacturer Narrative

Additional information: device available for evaluation, returned to manufacturer on: 03/17/2020.Device evaluation: visual inspection performed under microscope.Lubricant material residues and loose particles were observed on the lens surface.Both haptic were missing and there was marks on lens which could be related to the explant process.Based on the analysis the reported issue could not be verified, and product quality deficiency could not be determined.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 that one (01) additional investigation requests (irs) for this production order number has been received and no product deficiency was identified.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.Attempts were made to contact the customer account requesting additional information however, to date no response has been received.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
• 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: 9827939
• MDR Text Key: 183372005
• Report Number: 2648035-2020-00253
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474529021
• UDI-Public: (01)05050474529021(17)220420
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2022
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Is the Reporter a Health Professional?: Yes
• 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
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2017
• 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