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

Model Number VTICMO13.2

Device Problems Break (1069); Device Operates Differently Than Expected (2913); Torn Material (3024)

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

Event Date 06/26/2016

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But is not marketed in the u.S.Device evaluated by manufacturer? no.Claim #(b)(4).Lens not returned.

Event Description

The reporter indicated the surgeon attempted to insert a 13.2mm vticmo13.2 implantable collamer lens, -9.00/-2.50/170 diopter, and the lens tore/broke while injecting.The reporter indicated the haptic was catching on the foam tip plunger.There was no patient contact.The patient's best-corrected visual acuity (bcva) was 20/20.

Manufacturer Narrative

Additional information: work order search: no similar complaint was reported for units within the same lot."the reporter indicated that the surgeon attempted to insert a 13.2mm vticmo13.2 implantable collamer lens, -12/+2.00/080 diopter, and the lens tore/broke while injecting.The reporter indicated the haptic was catching on the foam tip plunger.There was no patient contact.The patient's best-corrected visual acuity (bcva) was 20/20." no material integrity issue reported.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5766315
• MDR Text Key: 48715192
• Report Number: 2023826-2016-00872
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2016

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: Physician
• Device Expiration Date: 02/28/2019
• Device Model Number: VTICMO13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 07/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 21 YR