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	Cataract, Induced (1767); Corneal Edema (1791); Hyphema (1911); Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	10/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Lens not returned.
Event or Problem Description
The reporter stated that the surgeon implanted a 12.1mm micl12.1 lens, -3.50 diopter, in the patient's right eye on (b)(6) 2016.The lens was explanted on the same day due to excessive vaulting, resulting in elevated intraocular pressure (iop), shallow anterior chamber, corneal edema, hyphema, and development of a cataract.
Additional Manufacturer Narrative
Device evaluation: product evaluation found that the lens was returned in liquid in the lens vial.Visual inspection found a small tear on the haptic.(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: 6054105
• Report Number: 2023826-2016-01523
• Device Sequence Number: 11221954
• Product Code: MTA
• UDI-Device Identifier: 00841542102629
• UDI-Public: (01)00841542102629(17)170131
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/10/2016

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
• Operator of Device: Physician
• Device Expiration Date: 01/31/2017
• Device Model Number: MICL12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2016
• Supplement Report FDA Received Date: 12/02/2016
• 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 UNK, LOT NUMBER UNK; INJECTOR MODEL UNK, LOT NUMBER UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR