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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS; PHAKIC TORIC INTRAOCULAR LENS
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STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS; PHAKIC TORIC INTRAOCULAR LENS Back to Search Results
Model Number TMICL12.6
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/20/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
The reporter states a 12.6mm tmicl12.6 implantable collamer lens -11.0/+2.0/071 (sphere/cylinder/axis) was implanted into the patient's eye on (b)(6) 2021.Reportedly, the lens was removed on the same date and replaced with an alternate lens because the patient needed a different power.
 
Additional Manufacturer Narrative
Please disregard the current claim as it is a duplicate of mfr rep# 2023826-2021-01673.Claim# (b)(4).
 
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Brand Name
IMPLANTABLE COLLAMER LENS
Common Device Name
PHAKIC TORIC INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
MDR Report Key12021866
Report Number2023826-2021-01993
Device Sequence Number19888501
Product Code QCB
UDI-Device Identifier00841542107006
UDI-Public00841542107006
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 05/27/2021
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 Date01/31/2022
Device Model NumberTMICL12.6
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/27/2021
Supplement Date Received by Manufacturer06/28/2021
Initial Report FDA Received Date06/17/2021
Supplement Report FDA Received Date07/31/2021
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
UNK.
Outcome Attributed to Adverse Event Required Intervention;
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