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 Therapeutic Response, Decreased (2271)

Event Date 11/22/2020

Event Type  Injury  

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.(b)(4).

Event Description

A healthcare professional reported explantation of an intraocular lens (iol) due to opacification.The patient had decreased visual acuity.Additional information has been requested however, additional information has not been received.

Manufacturer Narrative

Additional information has been provided in b.3, d.4, e.1, e.3, g.3, h.3, h.4, h.6 and h.10.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).

Manufacturer Narrative

Additional information has been provided in d.10, h.3, h.6 and h.10.The explanted lens was returned inside a plastic petri dish that was taped closed.Dried solution was observed on the lens.The optic was broken into two portions.The break was not a clean straight line.One haptic was dried in solution into a bent position.The lens was cleaned to remove the dried solution.The lens was cleaned to remove the dried solution and re-evaluate.No opacification was observed.The optic has a long line of cracks in the outline of an instrument used to grasp the lens, present on one optic portion center optic zone.The same type of lens damage was also observed on the anterior and posterior surfaces of the optic edges of both portions.These lines of damage extended from the edge toward the central optic zone.Additional small cracks were also observed.A power and resolution evaluation of the returned lens was attempted with the two portions of the lens.A 100% confirmation of optical resolution could not be confirmed due to the lens was returned in pieces with multiple areas of optic damage on the anterior and posterior surfaces.The power and resolution of each lens was 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Product history records were reviewed and documentation indicated the product met release criteria.Associated products are unknown.It is unknown if qualified products were used.The root cause cannot be determined for the reported event.The lens was cleaned to remove dried solution.No lens opacification was observed.The explanted lens was returned in pieces with multiple lines of cracked damage extending into the central optic zone.The cracks in the optic material were present directly opposite each other on the anterior and posterior surfaces and are similar in appearance to damage from instruments used to grasp the lens.The lens was returned in two portions, typical of damage that occurs to explant a lens.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.A power and resolution evaluation of the returned lens was attempted with the two portions of the lens.A 100% confirmation of optical resolution could not be confirmed due to the lens was returned in pieces with multiple areas of damage.The manufacturer internal reference number is: (b)(4).

• 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
• MDR Report Key: 11019080
• MDR Text Key: 221753757
• Report Number: 1119421-2020-01945
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.235
• Device Lot Number: 12233995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Date Manufacturer Received: 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention