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	Blurred Vision (2137)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.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 physician reported following the intraocular lens implantation which was implanted in 2014, the patient had experienced blurry vision and glistenings after four years from the implantation.Additional information has been requested and received stating the patient is waiting for an explant.No medication has been used to treat the event of glistenings.Artificial tears were used but no specific indication was mentioned, the patient did not have dry eyes.Eye inspection revealed no other pathology other than lens glistening.Patient had va of 20/20 but not clear vision.There was no harm to the patient and the patient issues have resolved.
Additional Manufacturer Narrative
The product was not returned for analysis.Two photos which appear to be the same photo at different magnifications were submitted and reviewed.The photo(s) were oblique slit beam photos focused in the center of the iol.The photo is of good clarity and is significant for diffuse refractive particles that appear to be located within the body of the iol.These particles are typically referred to as microvacuoles or glistenings.It is difficult to determine the depth of these particles from the photo, and etiology cannot be stated with certainty.Based on the content provided in the medical information review, microvacuoles/glistenings have been observed but the cause cannot be determined.A definitive determination of damage cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.Based on the results from the product history record, the products met release criteria.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: 14207761
• Report Number: 9612169-2022-00188
• Device Sequence Number: 14561716
• Product Code: HQL
• UDI-Device Identifier: 00380655093283
• UDI-Public: 00380655093283
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

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: 03/31/2016
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.245
• Device Lot Number: 21032225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARTIFICIAL TEAR (NOT SPECIFIC TREATMENT).
• Patient Age: 53 YR
• Patient Sex: Female