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

Model Number SOFTECHDO+19.75

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Deposits (1809)

Event Date 09/18/2017

Event Type  Injury  

Manufacturer Narrative

The lens was not returned to the manufacturer and no outside testing report was provided, thus no definitive corroboration on the complaint could be verified, no images or pictures were provided.However, the medical monitor indicated the most likely risk factor for a reported calcification is that the patient had a compromised blood retinal barrier.According to neuhann et al, non-lens factors are the likely cause.It would appear that the patient pre-existing condition is responsible for the event.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.Lenstec also confirms that all procedures in the manufacturing and packaging of the lens were conducted correctly.

Event Description

Lenstec received a call stating 'cloudy lens explanted and sent for outside lab analysis.'.

• Brand Name: SOFTEC HDO
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• Manufacturer (Section G): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• Manufacturer Contact: jimmy chacko ; 1765 commerce ave. n.; st. petersburg, fl ; 5712272
• MDR Report Key: 10106467
• MDR Text Key: 193317712
• Report Number: 9613160-2020-00055
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369037341
• UDI-Public: 00844369037341
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2020
• Device Model Number: SOFTECHDO+19.75
• Device Catalogue Number: SOFTEC HDO
• Device Lot Number: 151325
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2015
• 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