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

Model Number VTICM5_13.2

Device Problem Use of Device Problem (1670)

Patient Problem Blurred Vision (2137)

Event Date 01/03/2017

Event Type  Injury  

Manufacturer Narrative

Lens repositioning was performed on (b)(6) 2017 and the outcome was good.The patient's last visit was on (b)(6) 2017 with uncorrected visual acuity (ucva) 20/25.Work order search: no similar complaints were reported for units within the same lot.Conclusion code: the customer reported that the surgeon inadvertently implanted the lens interchanged between eyes.Claim # (b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens, -4.0/+1.5/172 diopter, in the patient's right eye (od) on (b)(6) 2016.The right eye (od) was implanted with the calculated left eye (os) lens, resulting in refractive surprise.Repositioning surgery is planned for (b)(6) 2017.

Manufacturer Narrative

Lens repositioning was performed on (b)(6) 2017 and the outcome was good.The patient's last visit was on (b)(6) 2017 with uncorrected visual acuity (ucva) 20/25.Work order search: no similar complaints were reported for units within the same lot.Conclusion code: the customer reported that the surgeon inadvertently implanted the lens interchanged between eyes.Claim # (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: 6284878
• MDR Text Key: 65998955
• Report Number: 2023826-2017-00155
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/03/2017

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: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: VTICM5_13.2
• 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: 01/03/2017
• Initial Date FDA Received: 01/27/2017
• Supplement Dates Manufacturer Received: 07/03/2017
• Supplement Dates FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2016
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 32 YR