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

Model Number	MICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Visual Disturbances (2140); No Consequences Or Impact To Patient (2199); Halo (2227); No Code Available (3191)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Work order search: no similar complaint type events were reported for units within the same lot.Patient code: (b)(4) secondary surgical procedure, enlargement of pi, addition of new pi, explant.Patient code: (b)(4) significant reduction of irido-corneal angles, pigment dispersion.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2 mm micl13.2, -12.0 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2018.On (b)(6) 2018 the lens was removed due to observation of excessive vault, elevated iop (intraocular pressure), significant reduction of irido-corneal angles, pigment dispersion, and glare/haloes.Additional surgical intervention (enlargement and addition of new pi) were performed.Additional information reported; decreased cell and flare + removal.Patient reports decrease in glare.
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid in a thermo scientific container.Visual inspection found haptic torn.Corrected data: pre-existing condition: axial length greater than 29.Condition should have been mentioned in initial mdr.(b)(4).
Additional Manufacturer Narrative
(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: 7631451
• Report Number: 2023826-2018-00930
• Device Sequence Number: 1719135
• Product Code: MTA
• UDI-Device Identifier: 00841542103336
• UDI-Public: 00841542103336
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2018

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: 09/30/2019
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 06/12/2018; 08/28/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 08/09/2018; 08/28/2018
• 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: 28 YR