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

Model Number EMERALDC30

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

The cartridge is not implantable device; therefore, not explanted.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the tip of an emeraldc30 cartridge had an error/damage prior to loading the lens into the cartridge.There was no patient injury.No additional information was provided.This report is one (1) of two (2).

Manufacturer Narrative

Device available for evaluation, returned to manufacturer on 3/13/2018.Device evaluation: the two (2) emeraldc30 cartridges were received in a plastic bag.Visual inspection using microscope magnification was performed.Sample #1 the cartridge was observed with the tip deformed.Evidence of viscoelastic residues, ovd (ophthalmic viscosurgical device), was observed in the cartridge tube, tip, wings, and loading zone.Based on the evidence observed, this cartridge has been handled and prepared for surgical use.Sample #2 the cartridge was observed with the tip deformed.Evidence of viscoelastic residues, ovd (ophthalmic viscosurgical device), was observed in the cartridge tube, tip, wings, and loading zone.Based on the evidence observed, this cartridge has been handled and prepared for surgical use.The deformed tip condition observed on both returned samples (#1, and #2) is consistent with units that have been damaged by accident while inserting the cartridges into the metal slot of the handpiece during the surgical process.The reported issue was verified on the two samples returned.There is no evidence to suggest that the complaint samples have been affected by the manufacturing process.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions, precautions, and warnings 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• 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: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7350269
• MDR Text Key: 102876001
• Report Number: 2648035-2018-00397
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)180713(10)CC08491
• Combination Product (y/n): N
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2018

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 Expiration Date: 07/13/2018
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CC08491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2017
• 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