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

Model Number TMICL12.6

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).No similar complaint type events were reported for units within the same lot.(b)(4).

Event 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.

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).

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)
• Type of Device: IMPLANTABLE COLLAMER LENS (ICL)
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9087432
• MDR Text Key: 159174406
• Report Number: 2023826-2019-01725
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542106948
• UDI-Public: 00841542106948
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 12/13/2019; 04/28/2020
• Supplement Dates FDA Received: 01/08/2020; 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL: SFC45, LOT#: 1442266; INJECTOR MODEL: MISPF, LOT#: 1445626; INJECTOR SYSTEM MODEL: FTP, LOT#: 1442115
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR