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

Model Number VTICMO13.2

Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

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

Event Date 05/19/2015

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.Unk event problem and evaluation codes: patient: new incision, secondary surgery, refractive surprise.Device: explanted.Method: work order search.Results (evaluation result): a lens work order search was performed and no similar complaints were found within the work order.Conclusion - (unable to confirm complaint): based on the complaint history and work order search, a specific root cause of the event could not be determined.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens, -13.5/+1.5/063 diopter, in the patient's right eye (od) on (b)(6) 2015.The lens was explanted on (b)(6) 2015 due to a refractive surprise.The lens was exchanged for another same model but different diopter lens and the problem was resolved.

Manufacturer Narrative

(b)(4).Device evaluation: product evaluation found that the lens was returned dry in case/vial.Visual inspection found the lens to have no visible damage.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: 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: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5325949
• MDR Text Key: 34300911
• Report Number: 2023826-2015-01712
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/16/2015

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: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2015
• 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
• Treatment: CARTRIDGE MODEL AND LOT NUMBER UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR