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

Model Number PCB00

Device Problems Difficult to Fold, Unfold or Collapse (1254); Failure to Fold (1255); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The following article was received based on a literature review: article: video analysis of optic-haptic-interaction during hydrophobic acrylic intraocular lens implantation using preloaded injectors an observational, retrospective study was done to compare the optic-haptic interaction of different hydrophobic acrylic intraocular lenses (iols) after using six preloaded injectors.The video-recordings of procedures on a total of 388 eyes (n=388 eyes) that underwent phacoemulsification and intraocular lens (iol) implantation were reviewed.For six preloaded injectors: multisert (hoya surgical optics) [system 1], tecnis simplicity (johnson & johnson vision) [system 2], tecnis itec (johnson & johnson vision) [system 3], autonome (alcon, laboratories) [system 4], bluesert (carl zeiss meditec) [system 5], and prosert (ophthalmopro gmbh) [system 6], the time of iol delivery and observation of iol insertion and optic-haptic-interaction were noted.A centurion (alcon, usa) or whitestar signature (johnson & johnson, usa) phacoemulsification machine were used for the surgeries.Systems 2 and 3 were used in implantation of the tecnis iols (tecnis dib00 and tecnis pcb00).The same ophthalmic viscosurgical device (ovd) (hydroxypropylmethylcellulose [20.0 mg]) at room temperature (20¿23° c) was used in all cases.Events included: deformed delivery behavior: system 2: in the leading haptic (19.5%) and in the trailing haptics (6.1%).System 3: in the leading haptic (14.1%) and in trailing haptics (4%).Adhesions: system 2 (43.9%): adhesion between two haptics (21.9%) and haptic-optic adhesion (21.9%) system 3 (52.5%): between two haptics (22.2%), and between haptic and optic (30.3%) system 2 (28.1%) and system 3 (32.3%) required additional manipulation to release the adhesion and perform rotational adjustments to optimize the iol¿s orientation within the central of the capsular bag.System 3 showed the longest mean delivery time (34.8 ± 9.8).There are no indications in the article of any interventions provided.A copy of the article is attached to this report.A separate report will be submitted for the system 2 lens.

Manufacturer Narrative

Section a2: mean age 68.6 ± 12.6.Section a3: 54 female and 45 male patients.Sections a4, a5: information unknown/not provided.Section b3: date of event: exact dates not provided.Article acceptance date is november 9, 2023.Section d4: catalog number: complete catalog number is unknown, as the serial number was not provided.Section d4: serial number: unknown, information not provided.Section d4: expiration date: unknown, as the serial number was not provided.Section d4: udi number: unknown, as the serial number was not provided.Section d6a - implant date: unknown/ not provided section d6b - explant date: n/a, lens remains implanted.Section h3 - other (81): the implant was not returned for evaluation as it remains implanted.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Section h4: device manufacture date: unknown, as the serial number was not provided.Citation: w.Yan, a.F.Borkenstein, r.Khoramnia, e.-m.Borkenstein, g.U.Auffarth; video analysis of optic-haptic-interaction during hydrophobic acrylic intraocular lens implantation using preloaded injectors; yan et al.Bmc ophthalmology; https://doi.Org/10.1186/s12886-023-03216-5.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 18908959
• MDR Text Key: 337750188
• Report Number: 3012236936-2024-00576
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P980040
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCB00
• Device Catalogue Number: PCB00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• 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