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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS

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STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS Back to Search Results
Model Number MICL13.2
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problems Intraocular Pressure Increased (1937); Missing Value Reason (3192)
Event Date 08/15/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Lens was returned dry, in a specimen container.Visual inspection found a torn haptic and residue on the lens surface.(b)(4).
 
Event Description
The reporter indicated that the surgeon implanted a 13.2mm, micl13.2, -14.0 diopter, implantable collamer lens into the patients right eye (od) on (b)(6) 2018.The lens was exchanged on (b)(6) 2018 with a shorter length lens due to pupil block with elevated iop (intraocular pressure), too large lens with ac shallowing, high vaulting and narrowing of angle.This exchange resolved the problem.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
IMPLANTABLE COLLAMER LENS (ICL)
Type of Device
PHAKIC INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
Manufacturer (Section G)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
Manufacturer Contact
cynthia thai
1911 walker avenue
monrovia, CA 91016
MDR Report Key7875111
MDR Text Key120235860
Report Number2023826-2018-01395
Device Sequence Number1
Product Code MTA
UDI-Device Identifier00841542103374
UDI-Public00841542103374
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
MTA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/15/2018
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 Date07/31/2019
Device Model NumberMICL13.2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/15/2018
Initial Date FDA Received09/13/2018
Supplement Dates Manufacturer Received10/29/2018
Supplement Dates FDA Received10/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age36 YR
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