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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF RESTOR TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF RESTOR TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number SND1T3
Device Problem Microbial Contamination of Device (2303)
Patient Problems Endophthalmitis (1835); Pain (1994); Visual Impairment (2138)
Event Date 08/27/2020
Event Type  Injury  
Manufacturer Narrative
Evaluation summary: the product was not returned for analysis. The 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. (b)(4).
 
Event Description
A physician reported that following a cataract surgery with an intraocular lens (iol) implantation, the patient felt eye pain and decreased vision. Eight days later, the patient was admitted to hospital; their visual acuities were checked as 0. 2 and the symptoms were initial diagnosed as intraocular infection. Additional information was provided indicating that the patient was admitted to the hospital a second time and underwent a vitrectomy. At present, the patient's vision has improved. Further information was reported that the hospital could not provide further relevant medication treatment due to privacy of the patient. For the conclusion that the patient's endophthalmitis was caused by lens, the hospital reported that they had tested all aspects of the operation, but no bacterial source was found. After that, two new unopened iols were sent to a third-party inspection company, and micrococcus luteus was detected on the surface of one of the crystals. Therefore, it was considered that endophthalmitis was caused by lens.
 
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Brand NameACRYSOF RESTOR TORIC SINGLEPIECE IOL
Type of DeviceLENS, INTRAOCULAR, TORIC OPTICS
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
8175514979
MDR Report Key10800550
MDR Text Key215025920
Report Number1119421-2020-01622
Device Sequence Number1
Product Code MJP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P040020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2021
Device Model NumberSND1T3
Device Catalogue NumberSND1T3T135
Device Lot Number12473977
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/06/2020 Patient Sequence Number: 1
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