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

Catalog Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Information (3190)

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

Weight: unk.Ethnicity: unk.Race: unk.Model #: unk.This product is not marketed in the us.(b)(4).

Event Description

The reporter indicated that an implantable collamer lens was implanted into patients left eye (os) and excessive vault was observed.Reporter indicated cause of evnet was "sizing issue." additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Corrected data: h4- 07-may-2019 in previous mdr is corrected to unk.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
• MDR Report Key: 9334499
• MDR Text Key: 167192772
• Report Number: 2023826-2019-02170
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

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: Health Professional
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 01/27/2020
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR