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

Model Number MA60AC

Device Problems Optical Decentration (1360); Device Damaged by Another Device (2915)

Patient Problems Retinal Detachment (2047); Vitreous Hemorrhage (2143); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/04/2021

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

Event Description

A non healthcare professional reported following an intraocular lens implant procedure, on (b)(6) 2021 following retina surgery the patient had vitreous hemorrhage, tractional retinal detachment, epiretinal membranes (erm) involving the macula.On (b)(6) 2021, the lens was exchanged in a secondary procedure due to the haptic seen prolapsed inferior into anterior chamber with slight decentration.Additional information has been requested.

Manufacturer Narrative

The lens was returned wrapped in gauze inside a small brown envelope viscoelastic was observed on the lens.One haptic was bent-gusset area.The haptic insertion area was also damaged.The lens met dimensional specifications for the approved plan view template for a lens.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Haptic damage was observed.It cannot be determined if the damage was present before the lens was explanted.The facility representative reported that the iol was implanted (b)(6) 2021.On (b)(6) 2021 the haptic was observed prolapsed into anterior chamber with slight decentration.The iol was explanted on (b)(6) 2021.The facility could not provide the product information.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
• 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: 14238631
• MDR Text Key: 290305898
• Report Number: 1119421-2022-00885
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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 Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male