MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC UNK_INTRALASE_FEMTOSECOND LASER

Model Number UNK-INTRALASE

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

Patient Problems Keratitis (1944); Visual Impairment (2138)

Event Date 01/20/2022

Event Type  Injury  

Manufacturer Narrative

Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Age: mean age 33 ± 12 years old.Gender: 11 males (73.3%) and 4 females (26.6%).Date of event: exact dates not provided.Article acceptance date is (b)(6) 2022.The study was conducted for surgeries performed between (b)(6) 2012 and (b)(6) 2020.Model number: complete model number is unknown, as the serial number was not provided.Catalog number: complete catalog number is unknown, as the serial number was not provided.Serial number: unknown, information not provided.Expiration date: unknown, as the serial number was not provided.Udi number: unknown, as the serial number was not provided.Device manufacture date: unknown, as the serial number was not provided.Device evaluation product testing could not be performed because the product was not returned.Therefore, a failure analysis of the complaint device cannot be completed, and the reported event cannot be confirmed.Manufacturing record evaluation: the manufacturing record review could not be performed, and complaint history were not reviewed since the serial number is unknown.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Citation: hamon, l.; schlötzer-schrehardt, u.; flockerzi, f.A.; seitz, b.; daas, l.; morphological characterization and clinical effects of stromal alterations after intracorneal ring segment implantation in keratoconus; february 2nd, 2022; graefe's archive for clinical and experimental ophthalmology (2022) 260:2299¿2308; https://doi.Org/10.1007/s00417-022-05572-2 all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The following article was received based on a literature review: article: morphological characterization and clinical effects of stromal alterations after intracorneal ring segment implantation in keratoconus.A monocentric retrospective case series was done to analyze the histological and (ultra)structural stromal tissue changes after femtosecond (fs) laser¿assisted intracorneal ring segment (icrs) implantation and their refractive and topographic effects in patients with keratoconus.A total of 15 patients with either keratectasia (n=1), keratoconus (n=13), or pellucid marginal degeneration (pmd)(n=1) underwent fs laser¿assisted icrs implantation.The fs laser technology used to all patients was the intralase fs laser (johnson & johnson vison).All patients still presented a clear peri-segmental stroma at 191 ± 143 days postoperative and thereafter developed various degrees of intrastromal lamellar channel deposits.In vivo confocal microscopy revealed diffuse linear and focal granular hyperreflective structures compatible with lamellar channel deposits and histologically, there was mild proliferation of fibroblasts and fibrosis (peri-segmental fibrosis).Two patients underwent a penetrating excimer laser¿assisted keratoplasty (both 8.0/8.1 mm diameter, double cross stitch suture) 3.1 and 7.0 years after fs-icrs implantation due to high residual irregular astigmatism with decreasing visual acuity.No further details were provided.

• Brand Name: UNK_INTRALASE_FEMTOSECOND LASER
• Type of Device: FEMTOSECOND LASER
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16567827
• MDR Text Key: 311528259
• Report Number: 3012236936-2023-00637
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-INTRALASE
• Device Catalogue Number: UNK-INTRALASE
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention