MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS MONOFOCAL TORIC; LENS, INTRAOCULAR, TORIC OPTICS

Model Number ZCT450

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Date of event: date unknown/ not provided.If explanted; give date: lens remains implanted, therefore not explanted.Phone: (b)(6).Device evaluation: the intraocular lens (iol) was not returned for evaluation as it remains implanted.Therefore, a failure analysis of the complaint device could not be performed.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification. a search revealed that no additional complaints for this order number have been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the left eye was treated with a toric intraocular lens (iol) on the (b)(6) 2020.A query was received with the question of iol rotation and only few details are available.Refraction pre-op: sph (sphere) +5.0 cyl (cylinder) -2.75 a (axis) 97°, refraction post-op: sph +0.75cyl -3.25 a 12°.Pentacam pre-op: asti with simk -1.0 @ 87°, strongly irregular asti with 3.8 d difference in the 3 mm zone axes are not 90 ° to each other and change.Pentacam post-op: asti with simk -1.1 @ 27°, strongly irregular asti with 2.7 d difference in the 3 mm zone axes are not 90 ° to each other and change.It is noticeable that the post-operative astigmatism has an axis that is different / rotated by almost 90 °.This suggests that the astigmatism was overcorrected with a torus that was too strong.Furthermore, the astigmatism is strongly irregular (different refractive powers in the hemispheres and zones, different axis positions in the hemispheres).The patient is happy with the results as the post-op refraction is vastly better than pre-op.No rotation will be performed as calculations show only minor improvements possible.No additional information was provided.

• Brand Name: TECNIS MONOFOCAL TORIC
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco 00610 ; * 00610
• Manufacturer Contact: somyata nagpal ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 11143976
• MDR Text Key: 231619956
• Report Number: 2648035-2021-07011
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474588905
• UDI-Public: (01)05050474588905(17)250223
• 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: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ZCT450
• Device Catalogue Number: ZCT4500210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 01/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2020
• 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