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

Model Number SN60WF

Device Problem Material Opacification (1426)

Patient Problem Visual Impairment (2138)

Event Date 09/08/2023

Event Type  Injury  

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.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that a patient came to the hospital with lenses implanted about 10 years ago.The inside of her intraocular lens became extremely cloudy and his/her visual acuity decreased to 0.6 from 1.5.(the notes that was took over the phone is attached.) apparently, the condition was such that the fundus cannot be seen.The patient will be visiting the hospital next week to have examined, and after that, the iol will be replaced.Due to the patient's request to be able to see, the customer was planning to replace the lens.The doctor believes that it was caused by the company lens.Additional information has been requested and received stating that causal relationship will be suspected when va is obtained after removal and replacement of the iol.Causality was unknown at this time.The patient just had surgery on the left eye last month.The left eye became clearer after the surgery and the difference in vision between the left eye and the right eye may have increased.A removal and replacement surgery was scheduled for the right eye.

Event Description

Additional information received stating that the company lens was exchanged for a non company lens.Information on power stating that the power of the replacement lens was 21.0d.

Manufacturer Narrative

Additional information was provided in b.5.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The lens was returned inside a plastic covered round petri dish.Solution was dried on the lens.Both haptics were broken in the gusset area.Only one haptic was returned.The optic was cut into three portions.This damage was typical in appearance to damage created to help remove a lens from the eye.Each portion had additional optic damage.The optic edge was nicked.The posterior and anterior optic surfaces were scratched.Two optic portions were cracked, with one cracked damage positioned near the center.The lens optic portions were cleaned with klrp for further evaluation.After removal of the dried viscoelastic, the lens portions were allowed to acclimate to room temperature.The optic was microscopically evaluated again.The lens did not appear to be cloudy.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if a qualified viscoelastic was used.The root cause cannot be determined for the reported complaint.The lens was returned cut into pieces, typical of damage created to help remove the lens from the eye.The optic portions had multiple areas of additional damage.Each lens was subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.The lens optic portions were cleaned with klrp for further evaluation.After removal of the dried viscoelastic, the lens portions were allowed to acclimate to room temperature.The optic was microscopically evaluated again.The lens did not appear to be cloudy.Within the complaint, the customer had suggested that the lens had a strong yellow appearance.This lens model was manufactured as a yellow lens model.No abnormalities were noted with the natural (yellow) color of the lens.This lens was manufactured march 26, 2011 and implanted on july 13, 2011.The photo review attached to this file indicated that " multiple slit lamp images were provided showing the reported cloudy iol.While it is not possible to conclusively discern the cause of the iol appearance, the presence of microvacuoles within an iol can appear as ¿cloudy¿ when viewed with off-axis illumination such as in these images." the manufacturer internal reference number is: (b)(4).

Event Description

Also, iol replacement was performed last saturday.Iol was removed and fixed out.This iol was divided into 3 sections at the time of removal.The removed iol had a strong yellowish color.Additional information received stating that the vision decrease outcome: recovered (same as before vision decrease), visual acuity after lens replacement: 0.9 - 1.0.There was a bleeding from the retina when changing lenses, but no particular problem.There was no evidence of fundus disease that would lead to decreased vision.The patient had had a laser posterior capsulotomy and did not have liquefied secondary cataract.Therefore, the doctor considers that iol caused decreased vision.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: 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: 17823485
• MDR Text Key: 324320915
• Report Number: 1119421-2023-01677
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WFJ230
• Device Lot Number: 12033742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 79 YR
• Patient Sex: Male