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

Model Number	TMICL12.6
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No similar complaint type events were reported for units within the same lot.Lens was returned in vial, in liquid.Visual inspection found haptic torn.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm tmicl12.6 implantable collamer lens, -9.5/2.5/067 (sphere/cylinder/axis), into the patient's left eye (os) on (b)(6) 2019.After insertion, the lens "flipped in the eye." the lens was successfully exchanged with an alternate lens." 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
Explant date: (b)(6) 20019.Patient code 2692: no known impact or consequence to patient.Patient code 3191 in original mdr is not applicable.Claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: the reporter indicted that the surgeon implanted a 12.6mm tmicl 12.6 implantable collamer lens of -9.5/2.5/067 (sphere/cylinder/axis) into the patients left eye (os) on (b)(6) 2019.After insertion the lens "flipped in the eye"."the lens was taken out and replaced with a different icl." (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8591938
• Report Number: 2023826-2019-00779
• Device Sequence Number: 11265450
• Product Code: QCB
• UDI-Device Identifier: 00841542106801
• UDI-Public: 00841542106801
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2019

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: TMICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 07/19/2019; 07/22/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 07/19/2019; 07/22/2019
• 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: 23 YR