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

Model Number ZCB00

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Date of event: unknown, not provided.Serial#: unknown/not provided.Catalog#: a complete catalog # is unknown, as product serial number was not provided.Expiration date: unknown as product serial number was not provided.Udi #: a complete udi # is unknown as product serial number was not provided.If implanted; give date: unknown, was not provided.If explanted; give date: not applicable as there was no indication the lens was explanted.Initial reporter: a last name was not provided.Device manufacture date: unknown, as the serial number of the device was not provided.Device evaluation: the product testing could not be performed as the product was not returned.The customer's reported complaint cannot be confirmed.Manufacturing record review: a manufacturing record review could not be performed as no serial number was provided.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.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

The customer reported the haptic stuck to optic after implantation of the lens.This required the surgeon to go in and unstick the haptic from the optic.The customer could not confirm or provided any additional specifics aside from the lens model as a zcb00.Reportedly, the event happened years ago.No additional information was provided.

• Brand Name: TECNIS 1-PIECE
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7546167
• MDR Text Key: 109316077
• Report Number: 2648035-2018-00781
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• 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: Other
• Type of Report: Initial
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: ZCB00
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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