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

Model Number	SN60WF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a broken lens.Additional information received stated that patient had persistent corneal swelling from the excessive manipulation required to cut and remove the fractured lens during initial procedure.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
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.Photo received showing intraocular lens (iol) resting on lens case base.One haptic appears to be broken and the optic is damaged.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received.The patient has been under anti-inflammatory medical treatment since the manipulation required to remove the broken lens caused severe corneal edema which is not resolved yet.
Additional Manufacturer Narrative
The complainant indicates the use of non company viscoelastic, which is not qualified to be used with the associated intraocular lens (iol) model.The root cause may be related to failure to follow instruction for use (ifu).Based on the information provided by the customer, a non-qualified ophthalmic viscosurgical device (ovd) was used for the implantation of the iol.The use of an non-qualified ovd may cause damage to the iol and potential complications during the implantation process.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• 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 ; 8007579780
• MDR Report Key: 17509375
• Report Number: 9612169-2023-00591
• Device Sequence Number: 6101447
• Product Code: HQL
• UDI-Device Identifier: 00380655093252
• UDI-Public: 00380655093252
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.230
• Device Lot Number: 25602821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/13/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BIOVISC; CENTURION VISION SYSTEM; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown