MAUDE Adverse Event Report: ALCON GRIESHABER AG VERTICAL MICROSCISSORS DSP TIPS; SCISSORS, OPHTHALMIC

Catalog Number 701.11

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Retinal Detachment (2047); Retinal Tear (2050); Visual Impairment (2138)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported via a clinical study that during a vitrectomy/ cataract combination surgery with the use of disposable ophthalmic product a patient experienced retinal tear, detachment of retina and decrease in visual acuity.Patient was hospitalized and intervention was given and the symptoms are still continuing.No further information expected as the details were received from a clinical study.This is six of eleven reports for this issue and represents the ophthalmic forceps.

Manufacturer Narrative

No lot number was identified within the study and therefore within this complaint, which is why the associated manufacturing documentation could not be reviewed.All product and batch history records are quality reviewed prior to product release, ensuring that all products on the market fulfill the relevant requirements.Since the questionnaire retrospectively collects data, no sample is available to be provided to the responsible site for an in-depth investigation.Not enough information was provided to properly complete an investigation.The root cause of this complaint could not be identified.The exact root cause for the customer¿s reported event is unknown.Therefore, no specific action can be taken.The manufacturer internal reference number is: (b)(4).

• Brand Name: VERTICAL MICROSCISSORS DSP TIPS
• Type of Device: SCISSORS, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer (Section G): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17200013
• MDR Text Key: 317847012
• Report Number: 3003398873-2023-00135
• Device Sequence Number: 1
• Product Code: HNF
• UDI-Device Identifier: 07612717069251
• UDI-Public: 07612717069251
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 701.11
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Sex: Female