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

Model Number VTICMO13.2

Device Problem Misfocusing (1401)

Patient Problems Blurred Vision (2137); No Code Available (3191)

Event Date 01/16/2015

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Mdr resubmitted per fda request.

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticmo13.2, -16.0/+2.0/169 (sphere/cylinder/axis), implantable collamer lens in the patient's left eye (os) on (b)(6) 2015.The lens was exchanged on (b)(6) 2015 with a same model and size, different diopter lens due to refractive surprise.The problem was resolved.

Manufacturer Narrative

(b)(4).Results: visual inspection of the returned product found one haptic torn.The lens was returned dry.The lens was rehydrated in bss for re-measurement.The lens length, width, diopter power and sphere were measured and the results of the measurements were compared against the original values and the lens was found to be in specification.Medical review - several factors may be involved in a post-operative refractive surprise, including inappropriate refractive surgical planning, a wrong lens calculation/selection, preoperative inaccurate determination of the eyes measurements to determine the power of the icl, induced refractive change by incisions, unstable cornea and/or refraction prior to implantation, cl-induced warpage, wrong lens, upside-down lens, misaligned lens, rotation, tilting, etc.Conclusions: based on the complaint history, work order search, medical review and the evaluation of the returned product, a specific root cause of the event could not be determined.Claim # (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
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6262927902
• MDR Report Key: 4803722
• MDR Text Key: 173451912
• Report Number: 2023826-2015-00169
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• 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: 01/22/2015

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: 05/31/2017
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 05/28/2015
• Supplement Dates Manufacturer Received: 04/28/2015
• Supplement Dates FDA Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR