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

Model Number	EMERALDT
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Expiration date: not applicable as these inserter unfolder are sterilized by the user at their suite.If implanted; give date: n/a (not applicable).The inserter unfolder is not an implantable device.If explanted; give date: n/a (not applicable).The inserter unfolder is not an implantable device.Telephone: (b)(6).Manufacture date: unknown all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the surgeon was unable to rotate the knob of the inserter as it was stuck, and that the fingers of the surgeon slipped causing the tip of the cartridge to touch and scratch the endothelium of the eye.The surgeon removed the cartridge tip from the patient's eye and applied a strong force and managed to rotate the knob.The lens was implanted normally.Through follow up we learned that the patient suffers from corneal edema caused by the scratch on the endothelium and medical intervention was prescribed.After testing the inserter, it was found that the emerald t inserter, had more resistance compared with the other emerald t inserters that they have.No further information provided.
Additional Manufacturer Narrative
Device evaluation: the device was returned for evaluation.Therefore, product testing was performed, however the third party manufacturer a fails to replicate the condition, the root cause could not be identified therefore the complaint could not be confirmed.Manufacturing record evaluation: the manufacturing record were review for the inserter could was performed and revealed no evidence of non conformance to the affected lot as a result of the investigation there is no indication of product quality deficiency all pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: UNFOLDER EMERALD
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 11335590
• Report Number: 2020664-2021-07010
• Device Sequence Number: 19065995
• Product Code: KYB
• UDI-Device Identifier: 15050474500126
• UDI-Public: (01)15050474500126(17)991231(10)2-129
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K961242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: EMERALDT
• Device Catalogue Number: EMERALDT
• Device Lot Number: 2-129
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ZA9003, CARTRIDGE.
• Outcome Attributed to Adverse Event: Required Intervention