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

Model Number EMERALDC30

Device Problems Difficult or Delayed Positioning (1157); Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

Expiration date: unknown, as the lot number was not provided.Lot number: unknown, information not provided.Udi number: a complete udi# is unknown, as the lot number was not provided.Device manufacture date: unknown, as the lot number was not provided.If implanted, give date: not applicable, as the product is not implantable.If explanted, give date: not applicable, as the product is not implantable.Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing record review could not be performed because the lot number of the complaint product is unknown.Labeling review: the directions for use (dfu) was reviewed.The 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.

Event Description

It was reported that a (b)(4) 21.0 diopter lens also became stuck in an emerald cartridge while implanting the lens into the patient's operative eye.Reportedly, the lens was partially delivered with the optic/haptic having contact with the operative eye.Therefore, the lens was not used and a (b)(4) 20.5 diopter lens was chosen as the replacement lens with use of a non-johnson and johnson cartridge instead of the emeraldc30 cartridge.Overall, there was no patient injury.No additional information was provided.This report encompasses the emeraldc30 cartridge associated with the 3rd implant attempt out of 3.

• Brand Name: EMERALD
• 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: 7546924
• MDR Text Key: 109360672
• Report Number: 2648035-2018-00787
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(10)UNKNOWN
• Combination Product (y/n): N
• 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: Physician
• 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: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 62 YR