MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60WF
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Codes	Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional 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.There are two medical device reports associated with this patient.This report is associated with the right eye.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following an intraocular lens (iol) implant procedure, the patient experienced iol opacification.A yag laser was performed.Visual acuity was noted as count fingers post laser treatment.The surgeon plans to exchange the iol.Additional information has been requested; however, further information has not been received.
Additional Manufacturer Narrative
Additional information provided in b.2., b.5., d.6b., d.9., h.1., and h.3., the manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated that the lens was exchanged in a secondary procedure by a another lens.
Additional Manufacturer Narrative
The product was not returned for analysis.The 2 slit lamp photos are grainy in appearance with low resolution.One right eye (od) and one left eye (os) image are very similar presentations however, od photo has a much better quality and focus (os image seems blurred or out of focus).Both slit lamp photos are in direct lighting, with a large conical beam focused on what appears to be the anterior surface of the iol (intraocular lens).There are large refractile particles on both images od os.Due to the lighting, it is difficult to determine the location (anterior surface, posterior surface, or within the iol) of these particles.Particles appear to be larger in size and more diffuse in presentation when compared with microvacuoles (typically located within the body of the iol).Particles of this size are typically located on the front and/or back surface of the iol and are due to proteins adhered to the iol.They appear to be more inflammatory in nature but difficult to determine the etiology of these particles.The root cause for the reported complaint could not be determined.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Iol (intraocular lens) returned in a plastic container.A significant amount of solution is dried on both surfaces of the iol.The optic has a cut though the center of the optic almost dividing the iol in two.The optic has scratches, marks, cracks.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING 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: 12247170
• Report Number: 9612169-2021-00159
• Device Sequence Number: 2772011
• Product Code: HQL
• UDI-Device Identifier: 00380652332682
• UDI-Public: 00380652332682
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.210
• Device Lot Number: 21242925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 09/02/2021; 10/05/2021; 02/10/2022
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 09/22/2021; 10/26/2021; 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2019
• 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