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 Hypersensitivity/Allergic reaction (1907); Pain (1994); Retinal Tear (2050); Discomfort (2330)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: 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 patient reported that following an intraocular lens (iol) implant procedure, the patient felt discomfort.She was told of a retinal breakdown and she had her retina sewn.On the 12th day after the operation, the condition is good.She has difficulties if it is necessary to look at the light.Additional information was provided that the postoperative period was without complications; the fundus is correct; everything is ok; the fundus is pink.Approximately one week following the procedure, she experienced eye pain.She was seen by her surgeon and he removed an eyelash from her eye and the symptoms improved, but she could still feel some discomfort.She also reported that approximately ten months following the initial procedure, the patient went to a different hospital for consultation for implantation of iol to the fellow eye.During the pre-check before surgery the doctor reports retinal tearing in the original eye.The doctor repairs the retina and now her condition is good.

Manufacturer Narrative

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

Manufacturer Narrative

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

• 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 00000 ; EI 00000
• MDR Report Key: 8373202
• MDR Text Key: 137236875
• Report Number: 9612169-2019-00026
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.235
• Device Lot Number: 21193092
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 03/27/2019; 05/31/2019
• Supplement Dates FDA Received: 04/23/2019; 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention