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

Model Number	SN6AT5
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, the physician noted that optic had a pattern of dark pigmentation on it, there was no evidence of any pigment dispersion in the eye at the time.The iol was explanted, and the backup lens was placed without complication.Additional information has been requested and provided that there was no hospitalization.
Additional Manufacturer Narrative
The product was 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).
Additional Manufacturer Narrative
In the initial mdr the test gram negative has been reported in d.10.Only half of the lens was returned taped inside the lens case base.The lens had been cut across the center.Viscoelastic and a small amount of blood were observed on the lens portion.A cracked area was also observed near the cut area.No dark pigment was observed on the returned lens portion.The lens was swabbed with a drop of water to dissolve the ovd.No abnormalities or dark pigmentation was observed.Product history records were reviewed and documentation indicated the product met release criteria.Associated delivery products were not provided.It is unknown if qualified associated products were used.The root cause for the reported "pattern of dark pigmentation" could not be determined.The returned lens portion was evaluated microscopically up to 400x.No dark pigmentation or abnormalities were observed.The other lens portion was not returned (surgeon sent for testing).It cannot be determined if the second portion was damaged or contained the reported dark pigment.All lenses are 100% inspected for cosmetic attributes, and foreign material would not have met alcon¿s release criteria.Each lens is also 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.Pathology results provided indicated "punctate material is gram-negative (gw).While it's nature is not entirely clear, it could potentially correspond to either calcification or contamination during processing." it cannot be determined if the second portion was damaged or contained the reported dark pigment.Associated products were not provided.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 15429773
• Report Number: 1119421-2022-01964
• Device Sequence Number: 4679561
• Product Code: MJP
• UDI-Device Identifier: 00380652251150
• UDI-Public: 00380652251150
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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: 02/17/2026
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.280
• Device Lot Number: 15152719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2021
• 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: GRAM-NEGATIVE (GW); PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown