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

Model Number MA60AC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Uveitis (2122); Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.(b)(4).

Event Description

A doctor reported that following bilateral intraocular lens (iol) implant procedures, a patient experienced bilateral decreased visual acuity.Approximately one year after the initial implant procedure, the patient became a patient of the reporting doctor.The patient at that point was (b)(6) years old with rheumatoid arthritis.The patient did present with uveitis constantly.The doctor then noticed what seemed like a layer forming on top of the iol and decided to remove the lenses.The iols were exchanged for the same model approximately 13 years after the initial implant procedures.There is still some bleeding in the left eye.Additional information has been requested, although the reporting doctor does not have further product information as he did not perform the surgery and the surgeon has since retired.There are two medical device reports associated with this patient.This report is for the left eye.

Manufacturer Narrative

Additional information was provided in d.10., h.3., h.6.And h.10.Evaluation summary: the lens was returned submerged in clear liquid in a specimen cup.One haptic is broken at the insertion area.The broken haptic portion was returned.The other haptic was pulled from optic and returned.This haptic has a bulbous area on one end which indicates that a weld was performed during the assembly process.There appears to be an unknown matter/substance visible on the explanted optic.The product investigation could not identify a root cause for the reported complaint.Not enough information was provided from the account for further investigation.Solution, damage, and what appears as an unknown matter (possibly organic in nature) was observed on the explanted lens.The directions for use provides information that this lens model was designed and intended as a replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery.Information in the file indicated the lens was implanted in 2006.The implanting surgeon retired and another surgeon took on this patient in 2007.At that time, the patient was a 6 year old child.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8842014
• MDR Text Key: 152679355
• Report Number: 1119421-2019-01217
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention