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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 TMICL12.1
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Capsular Bag Tear (2639)
Date of Event 06/28/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Pt info: unk.Explant date: na.Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
 
Event or Problem Description
The reporter indicated the surgeon was preparing to implant a 12.1mm tmicl12.1 implantable collamer lens, -13.00/+2.0/076 (sphere/cylinder/axis), into the patients right eye (od) on (b)(6) 2021 and the lens capsule was nicked during the primary incision point.The icl lens was implanted and remained implanted.Additional information has been requested but none has been forthcoming.
 
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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 Key12241293
Report Number2023826-2021-02893
Device Sequence Number3589996
Product Code QCB
UDI-Device Identifier00841542105118
UDI-Public00841542105118
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/28/2021
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 Date02/28/2023
Device Model NumberTMICL12.1
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/28/2021
Initial Report FDA Received Date07/28/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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