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

Model Number ZCB00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Sensation in Eye (1869); Blurred Vision (2137)

Event Date 10/05/2018

Event Type  Injury  

Manufacturer Narrative

Additional information: patient age/date of birth: unknown as information was not provided.If explanted: not applicable, as the iol remains implanted in the patient's ocular dexter (right eye).Device evaluation: product testing could not be performed because the product was not returned as the iol remains implanted in the patient's ocular dexter (right eye).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 dexter (right eye).Patient reported complaint of never adjusting to or liking their new vision.Through follow up, customer account provided additional information confirming 1-day post of visit the patient complained of blurry/hazy vision, foreign body sensation, and not being happy with vision.Patient was seen every month for 1 year with no improvement.Daily activities of shooting and photography were affected.There are no plans to explant the lens.No further information was provided.

• 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
• 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: 10716045
• MDR Text Key: 212467575
• Report Number: 2648035-2020-00769
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531734
• UDI-Public: (01)05050474531734(17)220612
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P980040
• 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
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2018
• 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
• Patient Outcome(s): Other