MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. UNFOLDER EMERALD; LENS, GUIDE, INTRAOCULAR

Model Number EMERALDXL

Device Problems Break (1069); Use of Device Problem (1670); Inaccurate Delivery (2339)

Patient Problem Capsular Bag Tear (2639)

Event Date 06/10/2021

Event Type  Injury  

Manufacturer Narrative

Patient information: unknown/no information.Unique identifier (udi) number: a partial udi was provided as the serial number was not provided.Expiration date: unknown as the serial number was not provided.If explanted; give date: not applicable as the hand piece is not an implantable device.If explanted; give date: not applicable as the hand piece is not an explantable device manufacture date: unknown as the serial number was not provided.The device was not returned for analysis.No serial number was provided for this device; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.Attempts have been made to obtain missing information; however, to date, no response has been received.

Event Description

It was initially reported that the lens injector wasn't working properly.Through follow-up additional information was provided explaining that the injector was broken/bent.The issue was noticed while trying to advance the lens through the injector.The injector was initially stuck and then the intraocular lens (iol) shot into the eye.The customer further explained that the lens fired into the vitreous cavity and had to be removed.Additionally, the surgeon stated the issue was not the lens, but a maintenance issue of the surgical equipment by staff.The injectors were supposed to be sent in for repair.He does not see a problem with johnson & johnson product.The patient is reported to be fine now.No further information was provided.

• Brand Name: UNFOLDER EMERALD
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12284809
• MDR Text Key: 265367188
• Report Number: 2020664-2021-07076
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Public: (01)(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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EMERALDXL
• Device Catalogue Number: EMERALDXL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention