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

Model Number	MICL 13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.Date of event: unk.Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm, micl13.2, -11.00 diopter, implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2019.Excessive vault was observed, surgeon plans to exchange lens with a shorter length lens.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Outcomes attributed to adverse event: required intervention to prevent permanent impairment/damage.Explant date: (b)(6) 2019.The lens was exchanged on (b)(6) 2019 for a shorter length lens and the problem was resolved.Type of reportable event: serious.Device evaluation: lens returned dry wrapped in gauze inside a biohazard bag with clear surgical debris on product.Visual inspection found haptic bent and gauze fibers on lens.(b)(4).Claim#: (b)(4).
Additional Manufacturer Narrative
Date of event is (b)(6) 2019.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
• MDR Report Key: 9200184
• Report Number: 2023826-2019-01955
• Device Sequence Number: 10874479
• Product Code: MTA
• UDI-Device Identifier: 00841542103312
• UDI-Public: 00841542103312
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• 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: 11/04/2019
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 10/30/2019; 01/09/2020
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/26/2019; 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 W/ FTP, LOT # UNK; INJECTOR MODEL- MSI-PF, INJECTOR LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR