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

Model Number ZA9003

Device Problems Break (1069); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Code Available (3191)

Event Date 11/03/2020

Event Type  Injury  

Manufacturer Narrative

If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.(b)(4).Device evaluation: product evaluation was not performed because the product has been discarded.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from 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 there were issues with an intraocular lens (iol).Reported handling/use error, loading issues, folding/unfolding issues, and broken haptic.It was noted wrong cartridge used.The lens was removed and replaced during the same procedure.However, an incision enlargement was required.The product was discarded.No other information was provided.

• 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: 11033453
• MDR Text Key: 222293419
• Report Number: 2648035-2020-00945
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474528970
• UDI-Public: (01)05050474528970(17)230622
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2023
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2018
• 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
• Treatment: 1MTEC30 CARTRIDGE, LOT# UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR