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

Model Number	TMICL13.7
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.7mm tmicl13.7; -10.50/2.0/086 (sphere/cylinder/axis) implantable collamer lens; was noticed to be defective and indicated "scratch or chunk out of lens".It was also noted there was patient contact and a back up lens was used.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: b5: the reporter indicated that a 13.7mm tmicl13.7; -10.50/2.0/086 (sphere/cylinder/axis) implantable collamer lens; was noticed to be defective and indicated "scratch or chunk out of lens".Lens implanted then explanted.It was also noted there was patient contact and a backup lens was used.Claim# (b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: lens was returned in a vial, dry.Visual inspection found the lens haptic torn with the lens covered in thick residue.H6 - type of investigation 3331 - device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: 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: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 14092563
• Report Number: 2023826-2022-01196
• Device Sequence Number: 4885008
• Product Code: QCB
• UDI-Device Identifier: 00841542111270
• UDI-Public: 00841542111270
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: TMICL13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 04/26/2022; 06/27/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 05/05/2022; 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown