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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS
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STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS Back to Search Results
Model Number TMICL12.6
Medical Device Problem Code Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes Intraocular Pressure Increased (1937); Iritis (1940); Pain (1994); Pupillary Block (2026); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 11/13/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).No similar complaint was reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm tmicl12.6 implantable collamer lens, -06.50/+1.0/018 (sphere/cylinder/axis), in the patients right eye (od) on (b)(6) 2020.The lens was explanted on (b)(6) 2020 due to excessive vaulting, pupil block with elevated intraocular pressure.The patient developed aqueous misdirection and experienced pain.The surgeon enlarged the pi by surgical procedure.Another icl lens was not implanted.The patient is improving, with some residual iritis.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
 
Additional Manufacturer Narrative
H3: device evaluation: the lens was returned in liquid, in a specimen cup.Visual inspection found one haptic torn.Claim # (b)(4).
 
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Brand Name
IMPLANTABLE COLLAMER LENS (ICL)
Common Device Name
PHAKIC TORIC INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
MDR Report Key10969886
Report Number2023826-2020-02884
Device Sequence Number871964
Product Code QCB
UDI-Device Identifier00841542106351
UDI-Public00841542106351
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 11/11/2020
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? No
Operator of Device Health Professional
Device Expiration Date06/30/2022
Device Model NumberTMICL12.6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2020
Initial Date Received by Manufacturer 11/11/2020
Supplement Date Received by Manufacturer01/05/2021
Initial Report FDA Received Date12/08/2020
Supplement Report FDA Received Date03/03/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
CARTRIDGE MODEL SFC-45 - LOT # 1495753; FOAM TIP PLUNGER MODEL FTP - LOT # 1495757; INJECTOR MODEL MSI-PF - LOT # 1442890
Outcome Attributed to Adverse Event Required Intervention;
Patient Age30 YR
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