MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SN6AT3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Intraocular Pressure Increased (1937); Visual Impairment (2138); Eye Pain (4467)

Event Date 08/11/2021

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 optician reported that after one day of an intraocular lens (iol) implant procedure the patient experienced headache, eye pain and had tension post-op 54 mmhg.Hcp performed a pressure relief via paracentesis and later explanted the iol.Additional information was requested.

Manufacturer Narrative

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

Event Description

Additional information was requested and received.Patient diagnosis with eye pressure elevation and myopia.The events outcome was unchanged.Due to events unscheduled medical treatment pars plana vitrectomy was performed.As per health care professional cause of event was flat anterior chamber.Flat anterior chamber was there due to strabismus surgery at patient age 5.

Manufacturer Narrative

The product was returned for analysis.Iol case returned opened in an unknown sealed peel pouch, adhered to unknown blister tray.A significant amount of solution is dried on both surfaces of the optic and haptics.Both haptics are intact.The optic is torn/split-cut and scratched/marked-rejectable.We are unable to determine the root cause for the reported complaint "explantation due to tension ".The returned iol shows evidence of possible handling by the customer due to the presence of solution dried on both surfaces of the optic and haptics.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.All product and batch history records are quality reviewed prior to product release.There have been no other complaints for this lot.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 12388495
• MDR Text Key: 268901615
• Report Number: 9612169-2021-00179
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 00380652250023
• UDI-Public: 00380652250023
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2021

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 Operator: Health Professional
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.265
• Device Lot Number: 21260282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 08/27/2021; 11/15/2021
• Supplement Dates FDA Received: 09/21/2021; 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH III CARTRIDGE C; MONARCH IOL INJECTOR, UNSPECIFIED; Z HYALIN
• Patient Outcome(s): Required Intervention
• Patient Sex: Female