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

Model Number SN60WF

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

Patient Problems Endophthalmitis (1835); Hyperemia (1904); Hypopyon (1913); Inflammation (1932); Uveitis (2122); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/17/2022

Event Type  Injury  

Event Description

A physician reported that following implantation of an intraocular lens (iol) the endophthalmitis occurred, the anterior chamber washout was performed and it did not subside.The iol was replaced with another one additional information was requested and received stating the patient experienced hyperemia, keratic precipitates, anterior chamber cells.Fibrin, anterior chamber flare, hypopyon, posterior synechia, vitreous clouding due to hyalosis asteroid.Vitrectomy was performed.The patient was treated with antibiotics and steroids.The surgeon suspects iol since symptoms disappeared quickly after iol removal.

Manufacturer Narrative

Device not returned.Complaint and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The product was not returned.The provided photos were clinically reviewed by global quality customer affairs (gqca).Multiple photos were provided.Photograph analysis findings: of significance to the initial and amended report descriptions are the following findings: the visible conjunctival tissue appeared noninflamed in some of the photos.In other photos, the conjunctival tissue from 9 o¿clock to 11 o¿clock appeared moderately inflamed.The inferior conjunctival tissue appeared mildly inflamed.Many small, diffuse, white/gray-colored punctate opacities were visible within the miotic pupil.The exact location of the punctate opacities was indeterminate.A posterior chamber iol(intraocular lens) was also visible.A white linear semicircular opacity was visible within the center of the pupil.The product investigation could not identify a root cause for the reported endophthalmitis.The product was not returned.Based on the photographic findings and considering the information stated in the initial and amended report descriptions above, the association of the reported iol to the reported event cannot be confirmed.Information was provided that the symptoms resolved upon anterior chamber washing, vitrectomy and iol removal.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE 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: 15460442
• MDR Text Key: 300299673
• Report Number: 1119421-2022-02014
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WFA180
• Device Lot Number: 15231966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OPEGAN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male