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

Model Number UNKNOWN

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

Patient Problems Eye Injury (1845); Corneal Clouding/Hazing (1878)

Event Date 04/14/2022

Event Type  Injury  

Manufacturer Narrative

Age/date of birth (months): ages are 29.6 ± 8.5 (group 2min); 28.6 ± 7.5 (group 3min) sex, weight and ethnicity: unknown/ not provided.Date of event: exact dates not provided, article acceptance date is april 14, 2022.Model number: unknown, information not provided.A complete catalog number is unknown as the serial number was not provided.Serial number: unknown, information not provided.Udi number: a complete udi number is unknown, as the serial number was not provided.Device manufacture date: unknown, as the serial number was not provided.Device evaluation: the product testing could not be performed.The reported complaint cannot be confirmed.Manufacturing record evaluation: the manufacturing record review could not be performed because the serial number of the complaint product is unknown.Since the serial number is unknown, the complaint history review could not be performed.Conclusion: since the complaint product was not tested, and serial number is unknown, it is not possible to determine a malfunction and/or product quality deficiency.Citation: kelvin h wan, tommy cy chan, peter sk kwok & alex lk ng, combined accelerated collagen crosslinking and sub-bowman's keratomileusis in high myopic eyes: a comparison between total ultraviolet energy dose, (2022), seminars in ophthalmology, 37:5, 676-681.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: combined accelerated collagen crosslinking and sub-bowman's keratomileusis in high myopic eyes: a comparison between total ultraviolet energy dose.A retrospective comparative study was done to compare the safety, efficacy, and predictability outcomes of combined sub-bowman¿s keratomileusis (thin flap laser in situ keratomileusis [lasik]) and accelerated crosslinking (cxl) using two different irradiation durations.A total of 73 patients (n=73 eyes) were included for comparison.Forty eyes (n=40 eyes) received an energy dose of 2.16 j/cm2 (2-min protocol) and 33 eyes (n=33 eyes) had a total dose of 3.24 j/cm2 (3-min protocol).The lasik flaps were created using the 150-khz intralase femtosecond laser (abbort medical optics, chicago, il, usa), with a superior hinge, intended flap diameter of 8.5 mm and flap thickness of 90 ¿m.The flap was lifted for ablation and then repositioned for the irradiation doses.Corneal haze: month 1: 2-minute protocol (n=17 eyes); 3-minute protocol (n=20 eyes); month 3: 2-minute protocol (n=5 eyes); 3-minute protocol (n=5 eyes); month 6: 2-minute protocol (n=1 eye); 3-minute protocol (n=4 eyes).Demarcation line was present in the 2-minute (n=19 eyes; 47.5%) and 3-minute protocols (n=23 eyes; 69.7%).The corresponding line depth was 205 ± 52 m and 226 ± 80 m (p =.311).There was postoperative endothelial cell density loss of 198 ± 238 cells/mm2 for the 2-minute protocol and 192 ± 224 cells/mm2 for the 3-minute protocol.There are no indications in the article of any interventions provided.It was not clear whether these events were caused by the j&j device or other devices used in the study.

• Brand Name: UNK_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: 16587938
• MDR Text Key: 311740683
• Report Number: 3012236936-2023-00683
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNK-FEMTOSECOND LASER
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2023
• 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): Other