MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number	SN6CWS
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, a crack was observed on the lens after implantation.The iol was removed and replaced with a backup lens during the initial procedure.There was no patient harm.Additional information was requested.
Additional Manufacturer Narrative
The company device and the lens were returned separately inside the opened carton.The lens was returned inside a folded, taped suture package.Viscoelastic and blood were observed on the lens.Both haptics were broken from the optic and not returned.The optic was torn, cracked, and broken into several pieces.Four of the broken portions were returned.The used device was evaluated.Viscoelastic was observed in the device.The plunger was almost completely advanced.No damage was observed.Viscoelastic was not provided.It is unknown if a qualified product was used.The root cause cannot be determined for the reported complaint.The used device and explanted lens were returned.The reported lens damage was observed.It is unknown if a qualified viscoelastic was used in the device.Material properties of non-qualified ophthalmic viscosurgical devices may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12137592
• Report Number: 1119421-2021-01343
• Device Sequence Number: 4679187
• Product Code: KYB
• UDI-Device Identifier: 00380652249331
• UDI-Public: 00380652249331
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: SN6CWS
• Device Catalogue Number: SN6CWS.260
• Device Lot Number: 12725746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2019
• 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
• Patient Sex: Unknown