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	Headache (1880); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/30/2020
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 non-healthcare professional reported that, following the cataract surgery with intraocular lens (iol) implant procedure the patient suffered from several intolerances.Additional information received and stated that, since lens was implanted the patient had stinging in left eye, daily severe headaches, fingernails cracked, head overheated, optic nerve irritation, sand grain sensation which led hospitalization.Continuation of sicca therapy recommended additional information has been request.
Additional Manufacturer Narrative
The product was not returned for analysis.The root cause for the reported complaint could not be determined as no sample was returned for analysis.Based on the results from the product history record, the products met release criteria.Investigation has been completed based on current information.No further action is warranted at this time.There have been one other complaint reported in the lot.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that following the iol implant the patient experienced overheating at the head, forehead and all-round head, head throbbing, irritation of the left eye with burning, itching and stinging sensation.Pressure in the left eye towards the nose and irritation of the optic nerve.Can partly open the eye badly, due to sand grain feeling, listlessness, lack of energy/exhaustion, sleep disturbances and fatigue.The patient also had dry mouth and eyes, electro sensitivity, restlessness, weakness.Neuropathies, fingernail anomalies, cracked and breaking.Fingertips are sensitive to pain and unprotected.The patient assumes that the blue light filter is the disturber, sometimes more intense at least borderline.Muscle test or testing via bio resonance performed with different persons - left turning.Lymphocyte transformation test was performed and showed no evidence of type iv cellular sensitization to the tested material.Basophil degranulation test for allergen: eye lens iol: <50 pg/ml (values of > 200 pg/ml show an existing sensitization to the corresponding allergen.A detailed discussion of findings was made.The complaints cannot be explained ophthalmologically.There is no acute need for action.We recommend the continuation of the sicca therapy.In case of persistent complaints with periorbital pain we recommend a neurological evaluation with cardiac magnetic resonance imaging (cmri) of the orbit if necessary.

• 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: 15751580
• Report Number: 9612169-2022-00585
• Device Sequence Number: 15003477
• Product Code: HQL
• UDI-Device Identifier: 00380655093276
• UDI-Public: 00380655093276
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2023

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 Expiration Date: 06/30/2024
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.240
• Device Lot Number: 21250326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 11/09/2022; 01/20/2023
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 12/05/2022; 02/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2019
• 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: Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 60 KG