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

Model Number	MICL13.2
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Corneal Decompensation (1790); Corneal Edema (1791); Inflammation (1932); Intraocular Pressure Increased (1937); Pain (1994); Blurred Vision (2137); No Code Available (3191)
Date of Event	11/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Word order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm micl 13.2, -7.0 diopter, implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2018.Excessive vault, leading to corneal decompensation, uncontrolled iop, narrowing of the angles, corneal edema and shallowing of the acd was observed.Pain and blurry vision was reported as additional symptoms.Additional surgical intervention ( ac washout, icl "repostioning", repeat yag pi) was performed.It was reported that iop lowering drops and pills were prescribed.The lens was explanted on (b)(6) 2018.The explant resolved the high vault and iop.Patient is doing better but does have pigment on endothelium.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The reporter indicated that a 13.2mm micl13.2 implantable collamer lens of -7.0 diopter was implanted into the patient's right eye (od) on (b)(6) 2018.Excessive vault; corneal decompensation, uncontrolled iop, narrowing of the angles, corneal edema, inflammation, and shallowing of acd was observed.Pain and blurry vision were reported as additional symptoms.Additional surgical intervention (ac washout, icl repositioning, repeat yag pi) was performed.It was reported that iop lowering drops and pills were prescribed.The lens was explanted on (b)(6) 2018.The explant resolved the high vault and iop.Patient is doing better but does have pigment on endothelium.(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: 8159605
• Report Number: 2023826-2018-01833
• Device Sequence Number: 2010037
• Product Code: MTA
• UDI-Device Identifier: 00841542103237
• UDI-Public: 00841542103237
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: MICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 02/14/2019
• 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: 37 YR