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

Model Number	MICL12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pupillary Block (2026); No Code Available (3191)
Date of Event	12/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: product evaluation found that the lens was returned in liquid in a specimen cup with liquid.Visual inspection found no visible damage to lens.Patient code: (b)(4) narrowing of the angle, angle closure, addition of suture, secondary surgery, lens explant, phaco-emulsification, iol implant.Conclusion code: per dfu for this lens model, vicl's are contraindicated of implantations of a lens in a patient under the age of 21 years old.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6 mm micl12.6, -16.0 diopter, implantable collamer lens in the patient's right eye (od) on (b)(6) 2017.The lens was explanted on (b)(6) 2017 due to excessive vaulting, (pupiliary block) elevated iop, narrowing of the angle, and angle closure.One suture was used on removal.Phaco- emulsification was performed on the patient and an iol lens was implanted.The problem was resolved.Its is noted that the patient weighed her options and decided to receive an iol over another icl.
Additional Manufacturer Narrative
Corrected data: combigan, travatan, and diamox were administered for treatment of the icl removal.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7246094
• Report Number: 2023826-2018-00151
• Device Sequence Number: 11081870
• Product Code: MTA
• UDI-Device Identifier: 00841542103145
• UDI-Public: 00841542103145
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2018

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: 06/30/2019
• Device Model Number: MICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR