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

Model Number	MICL 13.2
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)
Health Effect - Clinical Codes	Corneal Decompensation (1790); Corneal Edema (1791); Inflammation (1932); Intraocular Pressure Increased (1937); Pain (1994); Blurred Vision (2137); Visual Disturbances (2140); 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 left eye (os) 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, and mild mydriasis, likely contributing to glare complaint.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Corrected data: the reporter indicated that a 13.2mm micl13.2 implantable collamer lens of -7.5 diopter was implanted into the patient's left eye (os) on (b)(6) 2018.Excessive vault, corneal decompensation, uncontrolled iop, narrowing of the angles, corneal edema, and shallowing of the 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 and mild mydriasis likely contributing to the glare complaint.Patient code 3191: secondary surgical intervention, narrowing of angles, shallowing of acd, ac washout, icl repositioning, yag pi, iop lowering drops and pills, explant, mydriasis (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: 8159607
• Report Number: 2023826-2018-01834
• Device Sequence Number: 2120799
• Product Code: MTA
• UDI-Device Identifier: 00841542103244
• UDI-Public: 00841542103244
• 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: 05/31/2020
• Device Model Number: MICL 13.2
• 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