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

Model Number SN6AT4

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

Patient Problem Zonular Dehiscence (2698)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

The product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that following an intraocular lens (iol) implant procedure, the patient reported dysphotopsia.The case went perfectly and her vision is excellent.The physician asked the patient to wait a few weeks to see if the condition would subside, but it did not.The physician sent the patient for a second opinion and that physician exchanged the iol for a different manufacturer's iol.Additional information was provided by the original physician that the patient experienced significant positive and negative dysphotopsia starting the day after the initial procedure.Additional information was provided by the patient that the original physician told her she had weak zonules.The patient also reported that the second physician did not say she had weak zonules.

Event Description

Additional information was provided by a certified ophthalmic assistant, who reported that the patient's issues have resolved.The prognosis is excellent.

Manufacturer Narrative

Additional information provided in description of event or problem, test/laboratory data, other relevant history, initial reporter also sent reports to fda, device evaluated by mfr, adverse event problem, and additional narrative.Evaluation summary: the device was received by a company representative and is in transit to the manufacturing site for investigation.Investigation including root cause analysis will be completed.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).

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6., and h.10.Product evaluation: the iol was returned for analysis and the reported complaint could not be confirmed.Additional observations were as follows: iol was returned cut in half in a specimen container.The segments are adhered to each other with solution.Solution is dried on both surfaces of the optic and haptics.The optic is torn/split-cut dividing the iol in two(2) and scratched/marked-rejectable.Optical power & resolution could not be verified due to the extensive optic damage.The root cause for the reported complaint could not be determined.An impact to the visual acuity of the patient cannot be verified by examination of the returned product.Based on these investigation findings, we are unable to verify if the iol contributed to the event.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

Event Description

Further information was provided by the original physician that the patient had positive and negative dysphotopsias.The clinical reason for explantation was "unbearable", and "unable to drive at night".Symptoms resolved after iol exchange.

Manufacturer Narrative

Additional information provided in b.5.And e.1.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• MDR Report Key: 9364523
• MDR Text Key: 168176184
• Report Number: 9612169-2019-00372
• Device Sequence Number: 1
• Product Code: MJP
• 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,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.195
• Device Lot Number: 21223524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III D CARTRIDGES, 8065977763, HWV; MONARCH III IOL DELIVERY SYST, 8065977773, APD; UNSPECIFIED PROVISC OVD, 000451, BEL
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR