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

Catalog Number	611.75
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Capsular Bag Tear (2639)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3003398873-2022-00040
• Device Sequence Number: 20286773
• Product Code: HOC
• UDI-Device Identifier: 07612717012233
• UDI-Public: 07612717012233
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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 Catalogue Number: 611.75
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown