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

Lot Number	163711
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Deposits (1809)
Date of Event	11/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the initial report (documentation analysis, complaint history and investigation of the returned lens) lenstec concludes that there is no evidence to suggest that any aspect of the lens was responsible for this incident.Microscopic examination of the lens indicated that the deposits seen were deemed superficial, did not stain for calcium and did not extend through the matrix of the lens.Moreover, lenstec is unable to determine a definitive conclusion as to the cause, however, the patient suffered from kidney disease.Additionally, lenstec can confirm that the lens, its design and the manufacturing process are not at fault due to the extensive testing that we have performed on this model.Furthermore, there have never been any confirmed lens-related cases of clouding, discoloration or opacification for our hema lenses.
Event or Problem Description
Lenstec received an email stating "lens implanted (b)(6) 2017.Patient has kidney disease but is not on dialysis at this time.Patient presented with fuzzy vision.Yag was performed to correct issue.Yag did not resolve issue.Doctor removed the lens and noted the lens was cloudy looking.".

• 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: 9576400
• Report Number: 9613160-2020-00002
• Device Sequence Number: 2490331
• Product Code: HQL
• UDI-Device Identifier: 00844369029308
• UDI-Public: 00844369029308
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2020

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: 10/18/2021
• Device Lot Number: 163711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1