MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. 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 Disturbances (2140); Halo (2227)
Date of Event	04/03/2024
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 consumer reported that following the intraocular lens (iol) implant procedure the patient experienced blurry distances vision.The vision was not sharp as before.The patient was not able to read words on tv screens or projected slides and not able to perceive the depth of scars on uneven pavements while walking.The patient was experiencing star like instances , (saturn) roundish bodies surrounded by an equatorial ring) , spiky blobs like sauces.The measured and recovered visual power was 10/10 on left eye.But patient perception was individual letters of any size don¿t appear as straight segments, but as twisted (zigzag) segments.The patient had sharpness issue.
Additional Manufacturer Narrative
The product was not returned for analysis.The reporting facility did not provide a lot number or any identification of the product.The root cause for the reported complaint could not be determined, not enough information was provided to complete the investigation.All product history records are quality reviewed prior to product release.Investigation has been completed based on current information.No further action is warranted at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19219592
• Report Number: 9612169-2024-00384
• Device Sequence Number: 15502545
• Product Code: HQL
• UDI-Device Identifier: 00380655095713
• UDI-Public: 00380655095713
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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.150
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 07/23/2024
• 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