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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Deposits (1809); Inflammation (1932); Intraocular Pressure Increased (1937); Vomiting (2144); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Weight: unk.Race: unk.Ethnicity: unk.Date of event: unk.Expiration date unk.Explanted: na.This product is manufactured in the u.S.But not marketed in the u.S.Manufacturer date: unk.(b)(4).Claim # (b)(4).
 
Event Description
The reporter indicated the surgeon implanted an icl implantable collamer lens, in the patient's right eye (od), in (b)(6) 2008.At post-op 3 hours, the patient had severe nausea and vomiting, but no eye pain.The intraocular pressure was elevated.Post-op there was anterior chamber inflammation and appearance of diffuse whitish precipitates on the anterior surface of the crystalline lens, hypotony and mid-dilated mildly reactive pupil.With administration of topical and systemic steroids, the anterior chamber reaction subsided, and the anterior capsular deposits gradually resolved peripherally with some remaining centrally over the course of several weeks.The patient's visual acuity at 6 months was 20/20.The lens remains implanted.The cause of the event was due to retained viscoelastic in the eye, use of myostat and some iris manipulation in a hyperopic patient.The event was not due to the icl lens.
 
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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
Manufacturer (Section G)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia, ca
Manufacturer Contact
cynthia thai
1911 walker avenue
monrovia, ca 
3037902237
MDR Report Key9759552
MDR Text Key183428139
Report Number2023826-2020-00316
Device Sequence Number1
Product Code MTA
Combination Product (y/n)N
Reporter Country CodeLE
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Physician
Type of Report Initial
Report Date 01/30/2020
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
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/30/2020
Initial Date FDA Received02/26/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age23 YR
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