MAUDE Adverse Event Report: LENSTEC BARBADOS INC. SOFTEC I; INTRAOCULAR LENS

Model Number	SOFTECI+18.5
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A full audit of all batch documentation relating to the production of the device was performed.The audit concluded that all procedures in manufacturing and packaging of the device had been conducted correctly.Batch reconciliation was 100.0%.Based on the assessment of our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Microscopic examination of the lens indicated that the cloudiness seen was superficial, did not stain for calcium and did not extend through the matrix of the lens.Hence, we can find no evidence to suggest that there is any fault in the manufactured lens that would have brought rise to this opacification.Based on the review conducted on this case by lenstec' s medical monitor, it was concluded that any iol could potentially lose clarity in this intraocular environment created by the patient's ongoing medical conditions (diabetes and glaucoma).
Event or Problem Description
Lenstec received an email stating " dr.Noticed a frosted appearance on the lens and replaced with a competitors lens.".

• Brand Name: SOFTEC I
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 10541555
• Report Number: 9613160-2020-00061
• Device Sequence Number: 16770821
• Product Code: HQL
• UDI-Device Identifier: 00844369029384
• UDI-Public: 00844369029384
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2024
• Device Model Number: SOFTECI+18.5
• Device Catalogue Number: SOFTEC I
• Device Lot Number: 190318
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1