MAUDE Adverse Event Report: ALCON GRIESHABER AG FLEXIBLE IRIS RETRACTOR; CLIP, IRIS RETRACTOR

Catalog Number 611.75

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

Patient Problems Intraocular Pressure Increased (1937); Capsular Bag Tear (2639)

Event Date 05/01/2022

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 literature article stated that while using the iris hook they noted posterior capsule rupture or zonular fiber rupture with or without vitreous loss and post operatively intraocular pressure was high in patients.

Manufacturer Narrative

Additional information has been provided in sections h.6 and h.10.A review of the device history record could not be performed.Lot number of devices is unknown this is a clinical literature research; no further information can be obtained for the cases mentioned in the study.The studys purpose was to compare the incidence of complications between flexible iris retractor (fir) and a similar operation technique.The study describes that the rate for complications is higher with the alternative technique, than using the fir.Sample has not been returned for evaluation.Not enough information was provided from the account to properly complete an investigation.The root cause could not be identified by the investigation.There is no new risk discovered for the use of flexible iris retractors.No further actions required.Investigation has been completed based on current information.The manufacturer internal reference number is: (b)(4).

• Brand Name: FLEXIBLE IRIS RETRACTOR
• Type of Device: CLIP, IRIS RETRACTOR
• 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: 14797164
• MDR Text Key: 294945955
• Report Number: 3003398873-2022-00040
• Device Sequence Number: 1
• Product Code: HOC
• UDI-Device Identifier: 07612717012233
• UDI-Public: 07612717012233
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 611.75
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2022
• 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): Other