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

Model Number TMICL12.6

Device Problems Difficult to Fold, Unfold or Collapse (1254); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

Sex: unk.Weight: unk.Ethnicity: unk.Race: unk.Device evaluation: the lens was returned in liquid, in lens vial.Visual inspection found the lens optic and haptic torn.Work order search: no similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon inserted and removed a 12.6mm tmicl12.6 implantable collamer lens, - 12.00/+1.5/087 (sphere/cylinder/axis), due to the lens unfolded incorrectly in the eye.The lens was replaced with another lens.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

Claim#: (b)(4).

Manufacturer Narrative

B5 - per updated information, it was reported that the lens tore during loading.There was no patient contact.The cause was reported as user error.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9319128
• MDR Text Key: 167194267
• Report Number: 2023826-2019-02165
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542107136
• UDI-Public: 00841542107136
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 01/16/2020; 01/27/2020
• Supplement Dates FDA Received: 01/16/2020; 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL: SFC-45, LOT# UNK; INJECTOR SYSTEM MODEL: FTP, LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK
• Patient Age: 35 YR