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

Model Number	TMICL12.6
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm, tmicl12.6, -10.50/2.5/055 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2019 and explanted on (b)(6) 2019.Reason for explant is unknown.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
Lens rotation was reported.The lens was explanted and replaced with a longer length/ different power lens on (b)(6) 2019, but the problem was not resolved.Claim# (b)(4).
Additional Manufacturer Narrative
B5 - 'the status of the eye is "irritated and tearing a lot".Post-op ucva is 20/20.' should have been included in supplemental mdr#1 claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: IMPLANTABLE COLLAMER LENS (ICL)
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9087432
• Report Number: 2023826-2019-01725
• Device Sequence Number: 2459211
• Product Code: QCB
• UDI-Device Identifier: 00841542106948
• UDI-Public: 00841542106948
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2019

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: 09/30/2020
• Device Model Number: TMICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 12/13/2019; 04/28/2020
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 01/08/2020; 04/29/2020
• 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: SFC45, LOT#: 1442266; INJECTOR MODEL: MISPF, LOT#: 1445626; INJECTOR SYSTEM MODEL: FTP, LOT#: 1442115
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR