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

Model Number VTICMO13.2

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Eye Injury (1845); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k): this product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Lens work order search-no similar complaint type events reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that as the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens, -9.5/+1.5/080 (sphere/cylinder/axis) into the patient's left eye (os), the lens tore/broke.This occurred on (b)(6) 2019.The lens was successfully exchanged intra-operatively.Patient injury occurred and the cause of the event is reported as unknown.

Manufacturer Narrative

B5-previously stated patient injury occurred.Corrected statement: no patient injury occurred.H6-clinical and health impact codes corrected.Device problem code 2993 corrected.Claim# (b)(4).

Manufacturer Narrative

H3 - device evaluation: lens was returned in a micro-centrifuge vial with moisture on the lens.Visual inspection found no visible damage to the lens.Corrected data: b2 - other serious or important medical events should be removed as it is not applicable.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 10708898
• MDR Text Key: 212253475
• Report Number: 2023826-2020-02435
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 11/03/2020; 01/22/2021
• Supplement Dates FDA Received: 11/24/2020; 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
• Patient Outcome(s): Other
• Patient Age: 20 YR