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

Model Number	MICL 12.6
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight:unk.Ethnicity:unk.Race:unk.Date of event:unk.Device evaluation : lens was returned dry, in lens case.Visual inspection found a haptic torn and bent.Residue on the lens was also observed.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm, micl12.6, - 16.00 diopter implantable collamer lens into the patients right eye (od) on (b)(6) 2019.On (b)(6) 2019 the lens was exchanged for a shorter length lens due to excessive vault.This exchange resolved the problem.Enlargement of pi (yag) was also reported as a secondary surgical intervention.In the reporters opinion the cause of this event was patient related factor.
Additional Manufacturer Narrative
Corrected data: h6 - patient code: 3189 should be corrected to 3191.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: 9484640
• Report Number: 2023826-2019-02417
• Device Sequence Number: 4202321
• Product Code: MTA
• UDI-Device Identifier: 00841542103145
• UDI-Public: 00841542103145
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: MICL 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/03/2020
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention