MAUDE Adverse Event Report: AST PRODUCTS, INC. BIOLI IOL DELIVERY SYSTEM; Folders and injectors, intraocular lens (iol)

Model Number	BIOLI-A1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a customer reported that the bioli iol delivery system, model bioli-a1, was used to implant the customer's ic-8 intraocular lens into patient's right eye on (b)(6) 2025.The iol optic was found to be "not clear" and "central posterior streaks" were observed by the surgeon upon slit lamp examination on the original date of surgery.The patient reported seeing "purple colors with total blurred vision" onset 1-day post-op on (b)(6) 2025.Secondary surgical intervention was performed on (b)(6) 2025 to exchange the lens and the patient outcome was reported as good.The surgeon thinks the likely cause of the damage was possible defect of delivery device.No additional supporting information has been received.
Additional Manufacturer Narrative
Dhr for device involved was reviewed and no abnormalities were found; the inspection results were found to be qualified.The device involved in the claim was not returned.Testing was conducted using a rentention sample taken from the same lot referenced in the claim.A lens was loaded into the retention sample and delivery was successful.No phenomena similar to the feedback received from the customer was observed during testing.Root cause could not be determined.

• Brand Name: BIOLI IOL DELIVERY SYSTEM
• Common Device Name: Folders and injectors, intraocular lens (iol)
• Manufacturer (Section D): AST PRODUCTS, INC.; 9 linnell circle; billerica MA 01821
• Manufacturer (Section G): ICARES MEDICUS; 4f, no. 16, sec. 2; sheng yi rd; zhubei, hsinchu 30261 ; TW 30261
• Manufacturer Contact: chanel figueredo ; 9 linnell circle; billerica, MA 01821 ; 9786674500
• MDR Report Key: 24004473
• Report Number: 1000635309-2026-00001
• Device Sequence Number: 10239544
• Product Code: MSS
• UDI-Device Identifier: 10814899027164
• UDI-Public: 10814899027164
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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?: No
• Device Model Number: BIOLI-A1
• Device Lot Number: FLJ1308
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown