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

Lot Number F1298

Device Problem Insufficient Information (3190)

Patient Problem Deposits (1809)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

Based on the review conducted on this case, lenstec was unable to perform a more thorough investigation of the complaint as the lens remains implanted.Therefore, we are unable to comment on the nature of the reported incident described and cannot corroborate the claim of actual opacification or make any definitive statement as to its cause.However, we can confirm that a lens of this nature would not have been shipped.Additionally, lenstec can confirm that all procedures in the manufacturing and packaging of the device were conducted correctly.Furthermore, lenstec confirms 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.Lenstec can also confirm that there have never been any confirmed lens-related cases of clouding, discoloration or opacification for our hema lenses.(b)(4).

Event Description

Lenstec received an email stating "cataract op on the left eye without complications on (b)(6) 2007, use of a monofocal iol +22.5 diopter.On (b)(6) 2019 finding that iol clouded on the left eye, iol exchange is required" the lens remains implanted.

• Brand Name: SOFTEC I
• 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 33716 ; 7275712272
• MDR Report Key: 8916545
• MDR Text Key: 155191414
• Report Number: 9613160-2019-00022
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369029544
• UDI-Public: 00844369029544
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P090022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2012
• Device Lot Number: F1298
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2007
• 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