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

Model Number SN60WF

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

Patient Problems Cataract (1766); Blurred Vision (2137); Visual Impairment (2138)

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 customer reported following the implant of an intraocular lens (iol), she experienced blurry vision, a laser treatment, and decreased visual acuity.The lens was 'cloudy'.The patient also experienced a secondary cataract because of the implanted lens.Additional information was requested.This is one of two associated reports filed for this facility.This report is for the right eye of the patient.The alcon reference numbers are: (b)(4).

Manufacturer Narrative

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

Event Description

Additional clarification received reports a laser treatment has not yet been performed, but is currently scheduled.The patient's visual acuity has decreased therefore the surgery was suggested.Additional information received reports the patient confused a secondary cataract with a cloudy lens.The patient was consulted and everything is reported as being 'okay.The lens is not cloudy but is reported to be in excellent condition.Additional follow up appointments will take place to monitor the patient.

Manufacturer Narrative

Additional information provided in g.1., g.2., h.3., h.6., and h.10.The product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause for the reported complaint.Not enough information was provided from the account for further investigation.Information was provided by the patient that, "the ophthalmologist removed the deposits with a laser and since then with the "repaired" eye the patient can see 100% sharp again." the patient also reported that, "all problems regarding eye lens are currently solved." it was also provided that a follow up email was received from eye care professional (ecp).Ecp reported that," the issue has been solved.The patient confused a secondary cataract with a cloudy lens.After consulting the patient via phone on that day, everything is ok.Patient informed that they have no further issues and are satisfied.The iol is not cloudy but in excellent condition." the manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in a.2., d.1., d.2., d.3., d.4., g.1., g.2., h.4., and h.6.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in b.5., h.3., h.6., and h.10.The product was not returned for analysis.The root cause for the reported complaint could not be determined.Information was provided by the patient that, "the ophthalmologist removed the deposits with a laser and since then with the "repaired" eye the patient can see 100% sharp again." the patient also reported that, "all problems regarding eye lens are currently solved." it was also provided that a follow up email was received from eye care professional (ecp).Ecp reported that," the issue has been solved.The patient confused a secondary cataract with a cloudy lens.After consulting the patient via phone on that day, everything is ok.Patient informed that they have no further issues and are satisfied.The iol is not cloudy but in excellent condition." all product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received reports the patient confused a secondary cataract with a cloudy lens.The patient was consulted and everything is reported as being 'okay.The lens is not cloudy but is reported to be in excellent condition.Additional follow up appointments will take place to monitor the patient.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork WV 00000 ; EI 00000
• MDR Report Key: 9226462
• MDR Text Key: 164130165
• Report Number: 1119421-2019-01777
• 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,foreign
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.175
• Device Lot Number: 21169622
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 11/19/2019; 12/20/2019; 01/17/2020; 02/17/2020
• Supplement Dates FDA Received: 12/10/2019; 01/06/2020; 02/14/2020; 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR