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

Model Number VICM5_13.2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endophthalmitis (1835); Retinal Detachment (2047); Toxic Anterior Segment Syndrome (TASS) (4469)

Event Date 11/15/2023

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens, -12.00 diopter, into the patients right eye (od) on (b)(6) 2023.The lens was removed on (b)(6) 2023 due to endophthalmitis was observed.Diagnostics of blood sampling was performed.Anterior chamber cleaning was performed.Medication was administered (melothene conjunctivalization injection/anterior chamber lavage).Vitreous surgery was performed and an iol was implanted.Post-op, vitreous retinal detachment treatment, oil injection surgery, laser treatment gas and anterior chamber lavage.The cause of the event was unknown.Patients current condition was visual acuity at hand motion level, treatment is on-going.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

H6: health impact - additional surgery: 4625 - anterior chamber cleaning/lavage; vitreous surgery, iol implanted.H6: health effect impact code: 4644 - melothene conjunctivalization injection.H6 - work order search: no similar complaint was reported for units within the same lot.Claim#: (b)(4).

Manufacturer Narrative

Additional data: h6: health effect - clinical code (e): 2047.H6: health impact - additional surgery: 4625 - oil injection surgery; laser treatment gas.Corrected data: b5: the surgeon implanted a vicm5_13.2 implantable collamer lens -12.00 diopter, into the patient`s right eye (od) on (b)(6) 2023.The lens was removed on (b)(6) 2023 due to possible toxic anterior segment syndrome (tass) was observed.Additional diagnostic such as blood sampling was performed and infection was not confirmed.Subsequent treatments were: ac cleaning and medications were prescribe.Vitreous surgery was performed and an iol was implanted (the surgeon decided to insert an iol due to inflammation though it was not a cataract).Two days later, the iol was removed, retinal detachment treatment and oil injection surgery were performed.Additional treatments of laser treatment gas and anterior chamber lavage were performed.The cause of the event was unknown.The patients current condition is visual acuity is at hand motion level, the eye is calm and is currently aphakic, iol surgery is scheduled.H6: health effect - clinical code (e): 4469.Claim#: (b)(4).

Manufacturer Narrative

Additional data: type of investigation code: 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.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• 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: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18360972
• MDR Text Key: 330932803
• Report Number: 2023826-2023-05562
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00840311300976
• UDI-Public: 00840311300976
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2023

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: Health Professional
• Device Model Number: VICM5_13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 02/14/2024; 06/09/2024
• Supplement Dates FDA Received: 02/15/2024; 06/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/09/2023
• 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 SFC-45 - LOT # UNK.; FOAM TIP PLUNGER MODEL FTP - LOT # UNK.; INJECTOR MODEL MSI-PF - LOT # UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Sex: Female