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

Model Number	MICL 13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm micl 13.2, -12.0 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2020.Reportedly, lens is too big and causing narrow angles.Surgeon would like to exchange for a shorter length lens.Lens remains implanted.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information: b5: the reporter indicated that the surgeon implanted a 13.2mm micl 13.2, -12.0 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2021.Significant reduction of irido-corneal angles, glaucoma, pigment dispersion, and excessive vault were observed, the lens was exchanged for a shorter length lens on (b)(6) 2021.Cause of the event is reported as device, "wrong size".Per reporter on (b)(6) 2021, "the angle has opened more and the pressure is stabilized to normal.The doctor is closely watching the patient and checking her angles to see if she improves over time as the eye quiets down." additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.H6: health effect - clinical code - 4581 - pigment dispersion.H6: health effect - implant code - reported 2199 - update to 4629.H6: medical device problem code - reported 2993 - update to 1583.Claim #(b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned in liquid in a vial.Visual inspection found no visible damage.Dimensional inspection found the lens to be within specifications.Claim # (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
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 11651548
• Report Number: 2023826-2021-00887
• Device Sequence Number: 3657679
• Product Code: MTA
• UDI-Device Identifier: 00841542103336
• UDI-Public: 00841542103336
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2021

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: 10/31/2022
• Device Model Number: MICL 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 04/07/2021; 11/10/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 04/28/2021; 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female