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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 VICMO 12.1
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/22/2020
Event Type  malfunction  
Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.(expiration date): unk, no serial number reported.Pma/510k: this product is not marketed in the us.(device manufacturing date): unk, no serial number reported.(b)(4).
 
Event Description
The reporter indicated that a 12.1mm, vicmo12.1, -18.00 diopter, implantable collamer lens tore/broke before/during loading.It was reported that the damage was noted "after injected".Patient contact is unknown.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
 
Manufacturer Narrative
Additional information: h3-device evaluation: lens returned in a micro-centrifuge vial with moisture and residue/debris on product.Visual inspection found haptic torn and residue and debris on lens.Claim# (b)(4).
 
Manufacturer Narrative
Additional information: b5-the reporter indicated that a 12.1mm vicmo 12.1 implantable collamer lens of -18.00 diopter was broken while loading it on 22-07-2020.Reporter believes "it was while grasping the lens with front loading forceps." there was no patient contact.Corrected data: h6-investigation code 4110: lens work order search: no additional similar complaint type event(s) within associated lots were found.Claim# (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
MDR Report Key10484165
MDR Text Key216874962
Report Number2023826-2020-02003
Device Sequence Number1
Product Code MTA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup,Followup
Report Date 08/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2023
Device Model NumberVICMO 12.1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2020
Initial Date Manufacturer Received 08/03/2020
Initial Date FDA Received09/02/2020
Supplement Dates Manufacturer Received10/02/2020
11/30/2020
Supplement Dates FDA Received10/22/2020
12/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age23 YR
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