MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. UNKNOWN; SURGICAL ADJUNCTS

Model Number UNKNOWN

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Brand name: unknown, not provided.Lot: unknown, not provided.Udi: unknown, as the lot number was not provided.Expiration date: unknown, as the lot number was not provided.Not applicable as the cartridge is not an implantable device.Device manufacturing date: unknown, as the lot number was not provided.Attempts have been made to obtain missing information; however, to date no response has been received.All pertinent information available to (b)(6) has been submitted.

Event Description

It was reported that while inserting the lens into patient's operative eye, lens was injected before the cartridge was in the wound, so lens got stuck in the incision.The lens was removed and replaced without any patient injury.No other information was provided.

Manufacturer Narrative

Device evaluation: the product was not returned for evaluation; therefore, a device evaluation could not be performed.As the lot number is unknown for this event, it was not possible to perform a retained product investigation for the complaint.The reported complaint was not verified.Manufacturing records review: as the lot number is unknown for this event, it is not possible to perform any manufacturing record evaluation or complaint history review.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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.

• Brand Name: UNKNOWN
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7349794
• MDR Text Key: 102873725
• Report Number: 2648035-2018-00396
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: ZCB00 IOL (B)(4)