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

Model Number ZA9003

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a monofocal intraocular lens (iol), model za9003 was implanted on (b)(6) 2008.Then on (b)(6) 2019, the dislocated iol was picked up and fixed to the sclera.It was indicated that at the examination on (b)(6) 2019, the optical part of the iol had greatly inclined and the iol was fixed in the sac, but the zinn (zonule of zinn) was torn and the only 7 o'clock direction zinn had no tear and lens was hanging at this site.For this reason, an iol was explanted and a new lens was implanted on (b)(6) 2019 which that iol was fixed to the sclera.When explanted, the haptic was fixed in the sclera on both sides, but the root of the haptic would not fixed to the optic and the optic was rotating vertically, that the lens went up or down and rotating further in the eye.It is unknown if the replacement lens was lens johnson and johnson lens.It was noted that the status of the new lens which was reported to have been fixed sclera is unknown.There was no patient injury reported.No additional information was provided.

Manufacturer Narrative

Device available for evaluation, returned to manufacturer on: 12/06/2019.Device evaluation: the product was received at the manufacturing site in a petri dish.The lens is cut, most probably related to the explant.The lens has both haptics attached.One of the haptics is crimped, this could be related to the handling of the lens during the surgical procedures (implant and/or explant of the lens).The haptics tips are rough.The process engineer was consulted for testing of the returned lens.Process engineer indicated that a testing to a lens that has been prepared and eventually explanted at the surgical site may lead to ambiguous results.There is no indication that the damage on the lens, haptics included, that could be associated to the lens manufacturing process.Manufacturing records review: manufacturing record review cannot be performed since the serial number is unknown.A search of complaints related to serial number cannot be performed since the serial number is unknown.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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: 9479181
• MDR Text Key: 173450213
• Report Number: 2648035-2019-01348
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): Y
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/04/2020

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: ZA9003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• 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: 11/19/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 01/14/2020; 10/25/2020
• Supplement Dates FDA Received: 02/06/2020; 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention