MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A medical engineer reported that following an intraocular lens (iol) implant procedure, the patient experienced glare and other visual side effects.The slit lamp images and the pentacam images show glistening's.Diagnosed with glimmer vision, special on the left eye.The patient issue was not resolved.There are two medical device reports associated with this event.This report is associated with the left eye.Additional information has been requested; however, further information has not been received.
Additional Manufacturer Narrative
A sample device 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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Four images were submitted and reviewed.Both od and os slit lamp images are optic sections illuminating the center of the iols through dilated pupils.The images show what appear to be diffuse refractile bodies within the iols.The corresponding od and os pentacam images also demonstrate the presence of the refractile bodies appearing to be within the bulk of the iols consistent with microvacuoles such as associated with glistenings.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that, explanation has not yet been performed and according to the patient, they have not yet planned.

• 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: 12927439
• Report Number: 9612169-2021-00282
• Device Sequence Number: 5476117
• Product Code: HQL
• UDI-Device Identifier: 00380655093184
• UDI-Public: 00380655093184
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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: 05/31/2020
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.195
• Device Lot Number: 21136296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2015
• 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 Age: 78 YR
• Patient Sex: Male