MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number PCB00

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

Event Type  Injury  

Manufacturer Narrative

Section a2: age: mean age of 56.8 ±6.9 (from ages 41 to 72).Not specified if grouped with johnson & johnson implant.Section a3: gender: 23 (41.82%) males; 32 (58.18%) females.Not specified if grouped with johnson & johnson implant.Section a4: patient weight: unknown/not provided.Section a5: race/ethnicity: unknown/not provided.Section b3: date of event: (b)(6) 2023 (date article published).Section d4: catalog number: a complete catalog number is unknown, as the serial number was not provided.Section d4: serial number: unknown/not provided.Section d4: expiration date: unknown, as the serial number was not provided.Section d4: unique identifier (udi) number: unknown, as the serial number was not provided.Section d6a: if implanted, give date: unknown/not provided.Section d6b: if explanted, give date: not applicable, as there was no indication that the lens was explanted.Section h3 - other (81): the device was not returned for evaluation and the serial number for this device is unknown/not provided; therefore, no further product investigation can be performed.Should any further relevant information become available a supplemental medwatch will be filed.Section h4: device manufacture date: unknown, as the serial number was not provided.Citation: ong, l.F., oh, a., yi, j.K., gu, j.S., marvasti, a.H., nguyen, b.B., tran, d.B., lee, j.K.(2023).Refractive lens exchange - who is getting it, what are they getting, how are they doing? current opinion in ophthalmology, 34(4), pp.280-289.Doi: 10.1097/icu.0000000000000956.Attempts were made to obtain the missing information; however, no additional information has been received.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: refractive lens exchange ¿ who is getting it, what are they getting, how are they doing? a retrospective cohort study was done to provide a review of the literature on refractive lens exchange and present a retrospective analysis of 55 patients who underwent refractive lens exchange at a single practice.A total of 99 eyes of 55 patients underwent bilateral or unilateral refractive lens exchange (rle).Three eyes were implanted with tecnis eyhance dib00, two eyes were implanted with the tecnis itec preloaded pcb00, and four eyes were implanted with the tecnis synergy dfr00v.Other implanted iols include alcon acrysof acu0t0 (n=4 eyes), bausch + lomb envista mx60e (n=6 eyes), bausch + lomb envista mx60et (n=1 eye), alcon acrysof aspheric toric sa6at9 (n=2 eyes), alcon clareon vivity ccwet0 (n=1 eye), alcon clareon vivity ccwet3 (n=1 eye), alcon acrysof vivity dat015 (n=3 eyes), alcon clareon panoptix ccwtt0 (n=1 eye), alcon acrysof iq panoptix tfat00 (n=30 eyes), alcon acrysof iq panoptix tfat30 (n=12 eyes), alcon acrysof iq panoptix tfat40 (n=5 eyes), alcon acrysof iq panoptix tfat50 (n=3 eyes), and rxsight lal (n=21 eyes).Five percent (n=3) of eyes had elective lasik procedure due to dissatisfaction with post-operative visual outcomes.Eleven percent (n=6) of eyes underwent yttrium-aluminum-garnet (yag) capsulotomy for posterior capsular opacification between 30 and 270 days post-rle.It is not clear if these complications occurred in the eyes implanted with tecnis eyhance dib00, tecnis itec preloaded pcb00, tecnis synergy dfr00v or the other products.The adverse events reported in the study were not associated with the device in scope (inserters); these may be procedure-related or other device-related based on initial medical assessment.(thus, no complaint identified against the inserters).A copy of the article is provided with this report.This report is for the pcb00 lens.Separate reports are being submitted to capture the dib00 and dfr00v lenses.

• Brand Name: TECNIS IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18918790
• MDR Text Key: 337843992
• Report Number: 3012236936-2024-00690
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PCB00
• Device Catalogue Number: UNK-PCB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention