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 Pain (1994); Scarring (2061); Blurred Vision (2137); Visual Impairment (2138)

Event Type  Injury  

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.There have been no other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A consumer reported that during an intraocular lens (iol) implant procedure, an unknown lens that was initially implanted was removed due to white pieces of material adhered to the lens.A secondary lens was implanted to complete the procedure.The consumer reported experiencing eye pain during and after the procedure.Five days postoperatively, blurry vision and a film over the eye was noted.At the two week post-op visit, the patient reported cloudy vision.The patient was referred to a corneal specialist who noted corneal scarring and recommended a corneal transplant.The corneal transplant was performed four months following the implant procedure.The patient noted the issue has not been resolved as cloudy vision and a haze over the eye continues.This report is for the second lens implanted during the procedure.

Event Description

Additional information was received indicating the events were due to the explanted iol.It was reported the iol the consumer has implanted now is fine with "no issues".This file represents the explanted iol.

Manufacturer Narrative

Additional information provided in b.5., d.1., d.4.And h.10.Additional information was received indicating the initial iol reported was for the replacement iol.The file has been updated to reflect the correct lens model for the reported events.A lot number was not provided.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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

Event Description

Surgical notes were received and indicated that 2 white pieces of foreign material of unknown origin were noted to be adhered to the posterior side of the iol after it was implanted.The iol was flipped and the foreign material was removed.The iol was flipped back and while removing the viscoelastic, it was observed that the iol was submerging into the posterior chamber.The iol was removed, an anterior vitrectomy was performed and another lens model was implanted to complete the procedure.

Manufacturer Narrative

Product evaluation: the initial lens reported was the replacement lens.File was previously updated to reflect a 19.5 lens.The product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.Eight potential lot numbers were provided based on shipping/consignment records for the facility.Complaint history and product history records were reviewed for all eight products and documentation indicated the products met release criteria.There were no complaints for these eight lot numbers.Root cause: the product investigation could not identify a root cause for the reported events.Not enough information was provided from the reporter for further investigation.Gqca corresponded with the implanting surgeon about the patients' concerns.Surgeon indicated they would be addressing the patients concerns.The eight potential lot numbers were provided by gqca to surgeon on (b)(6) 2020.File will be reopened if new information is provided.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
• MDR Report Key: 9558738
• MDR Text Key: 173952430
• Report Number: 1119421-2020-00048
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.195
• Device Lot Number: 12527963
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FORCEPS; HEALON GV OVD; LIDOCAINE GEL; MICHOL; MIOSTAT; MN60AC.190, MP; MPF - FREE LIDOCAINE; MURO DROPS; NEO/POLY/DEX OINTMENT; TETRACAINE DROPS; UNK IOL; UNSPECIFIED BSS; UNSPECIFIED MONARCH IOL DELIVERY SYST; UNSPECIFIED VISCOAT OVD; UNK IOL
• Patient Outcome(s): Required Intervention