MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
A non-health care professional reported that following an intraocular lens (iol) implant procedure, based on the patient's biometry, the doctor targeted a slightly myopic refraction with a power of 20 d (ref -0.39).At post op, it was found that there was a myopic surprise of -2.75 d.The doctor had done the biometry again, confirmed no measurement error and suspected myopic surprise occurred due to a power error in the lens.Patient also experienced blurry distance vision.
Additional Manufacturer Narrative
Additional information has been provided in b2., b.5., and h.11.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury.No further reports required.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
As a result of an internal review of the file, it was determined that the doctor initially thought a power outage caused your myopic surprise but later confirmed that no outage had actually occurred.Patient refraction has finally reached the target for slightly myopia (-0.39 d) on day 10 post operation, distance vision is satisfactory.The initial report was submitted in error.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 19927070
• Report Number: 1119421-2024-01537
• Device Sequence Number: 8375102
• Product Code: HQL
• UDI-Device Identifier: 00380655093191
• UDI-Public: (01)00380655093191(17)280610(11)230613(10)15662176
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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 Model Number: SN60WF
• Device Catalogue Number: SN60WF.200
• Device Lot Number: 15662176
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/17/2024
• Date Device Manufactured: 06/13/2023
• 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 Age: 65 YR
• Patient Sex: Female