MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	AU00T0
Health Effect - Clinical Codes	Visual Impairment (2138); Foreign Body In Patient (2687)
Date of Event	11/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.Additional information has been requested.(b)(4).
Event or Problem Description
A customer reported that an intraocular lens (iol) was tilted in the patient's eye and that the front haptic was protruding out of the iris.The iol was implanted five weeks prior to reporting the event.A second procedure was scheduled to reposition or explant the iol.Current patient status is unknown.Additional information has been requested but not received to date.
Event or Problem Description
Additional information was provided, indicating that one week after the iol was inserted there was no problem.Approximately five weeks later, the iol was noted to be malpositioned.The optic was tilted and one edge was sticking out through the pupil and the vision was relatively poor.
Additional Manufacturer Narrative
Evaluation summary: the product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The viscoelastic was not provided.It is unknown if a qualified product was used.The product investigation could not identify a root cause.It is unknown if a qualified viscoelastic was used.Material properties of non-qualified viscoelastic may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.There have been no other complaints reported in the lot number.
Additional Manufacturer Narrative
Evaluation summary: the product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The viscoelastic was not provided.It is unknown if a qualified product was used.The product investigation could not identify a root cause.It is unknown if a qualified viscoelastic was used.Material properties of non-qualified viscoelastic may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was provided, indicating that one week after the intraocular lens (iol) was inserted there was no problem.Approximately five weeks later, the iol was noted to be malpositioned.The optic was tilted and one edge was sticking out through the pupil and the vision was relatively poor.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/ULTRASERT DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6202715
• Report Number: 1119421-2016-01753
• Device Sequence Number: 18939175
• Product Code: HQL
• UDI-Device Identifier: 00380652358231
• UDI-Public: 00380652358231
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2017

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: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: AU00T0
• Device Catalogue Number: AU00T0.180
• Device Lot Number: 12435852
• Other Device ID Number: 00380652358231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2016
• Supplement Date Received by Manufacturer: 02/28/2017; Not provided
• Initial Report FDA Received Date: 12/23/2016
• Supplement Report FDA Received Date: 11/02/2023; 03/29/2017
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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