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U.S. Department of Health and Human Services

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

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STAAR SURGICAL COMPANY ICL (IMPLANTABLE COLLAMER LENS); INTRAOCULAR LENS Back to Search Results
Model Number MICL13.2
Device Problems Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)
Patient Problems Intraocular Pressure Increased (1937); Pupillary Block (2026); Blurred Vision (2137); Prolapse (2475); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Results code(s): (operational problem): visual inspection of the returned product found no visible damage to the lens.The lens was returned in liquid.(b)(4).
 
Event Description
The reporter stated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -10.0 diopter, in the patient's right eye (od) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to excessive vaulting, elevated intraocular pressure (pupillary block), narrowing of the angle, angle closure, shallowing of the anterior chamber and iris prolapse.The patient experienced blurred vision.A secondary surgery was performed to laser the peripheral iridotomies and the lens was repositioned but the patient still had pressure issues.The lens was exchanged for a shorter lens.The patient's pupil has remained large with some shallowing of the anterior chamber but the issue has improved.The patient's post-op best-corrected visual acuity was 20/20.
 
Manufacturer Narrative
Method: (process evaluation): device history record review.Result: (no failure detected): based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within the established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Conclusion: (unable to confirm complaint): based on the complaint history, work order search, product evaluation, medical review and device history record review, a specific root cause of the event could not be determined.(b)(4).
 
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Brand Name
ICL (IMPLANTABLE COLLAMER LENS)
Type of Device
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
michelle andres
1911 walker avenue
monrovia, CA 91016
6263037902
MDR Report Key5710842
MDR Text Key47082825
Report Number2023826-2016-00807
Device Sequence Number1
Product Code MTA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/10/2016
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 Physician
Device Expiration Date07/31/2017
Device Model NumberMICL13.2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/10/2016
Initial Date FDA Received06/09/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/13/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2015
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 Age32 YR
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