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

Model Number VICMO12.1

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Intraocular Pressure Increased (1937); Vomiting (2144); No Code Available (3191)

Event Date 01/15/2015

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 12.1mm vicmo12.1 implantable collamer lens in the patient's right eye (od) on (b)(6) 2014.That evening after surgery the patient had headache and vomiting, suggestive of increased intraocular pressure.The patient has also complained of glare.At the last post-op visit, the patient's symptoms have subsided but intraocular pressure was 24.The lens remains implanted.The patient's post-op best-corrected visual acuity was 20/20.

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4) - intraocular pressure rise; vomiting; headache; (glare).Device evaluated by manufacturer? no.Lens implanted.Evaluation method: work order search.Results: a lens work order search was performed and no similar complaints were found within the work order.Conclusions - (no conclusion can be drawn): based on the complaint history and work order search, a specific root cause of the event could not be determined.(b)(4).

Manufacturer Narrative

Event problem and evaluation codes: method: (process evaluation): device history record review.Results: (evaluation result): a review of the device history record was performed and nothing was found in the manufacturing, sterilization and packaging processes of this lens that was likely to have contributed to the complaint.No root cause for the complaint was determined.Conclusion: (unable to confirm complaint): based on the complaint history, work order search and the device history record review, a specific root cause of the event could not be determined.(b)(4).

• Brand Name: VISIAN 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: 4542564
• MDR Text Key: 18893425
• Report Number: 2023826-2015-00176
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor,distributor,forei
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2015

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: 01/31/2017
• Device Model Number: VICMO12.1
• Other Device ID Number: DIOPTER -07.50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 02/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2014
• 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
• Treatment: CARTRIDGE MODEL AND LOT NUMBER UNK
• Patient Age: 22 YR