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

Model Number	MICL12.1
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure, Delayed, Uncontrolled (1936); Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.1mm micl12.1 implantable collamer lens, -16.0 diopter, in the patient's left eye (os) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to excessive vaulting, elevated intraocular pressure and narrowing of the angle.The patient experienced pain and was treated with medication.A refractive lens exchange was performed.The patient's post-op uncorrected visual acuity was 20/30.
Additional Manufacturer Narrative
No similar complaints were reported for units within the same lot.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6251929
• Report Number: 2023826-2017-00058
• Device Sequence Number: 13709387
• Product Code: MTA
• UDI-Device Identifier: 00841542102872
• UDI-Public: (01)00841542102872(17)170630
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2016

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
• Operator of Device: Physician
• Device Expiration Date: 06/30/2017
• Device Model Number: MICL12.1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; INJECTOR MODEL MSI-PF - LOT NUMBER UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR