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

Model Number PCB00

Device Problem Difficult to Insert (1316)

Patient Problem Capsular Bag Tear (2639)

Event Date 01/28/2022

Event Type  Injury  

Event Description

It was reported that the iol (intraocular lens) was implanted, but appeared to flip which caused a capsular rupture and required the vitrectomy probe to be used.Although the capsule was stable, the surgeon decided to remove the iol.It was decided not to implant another iol until the eye had settled.The lens was injected as normal and the surgeon was unsure why it had turned/ flipped.The lens was inserted and removed during same procedure.There was a 10 minute delay in the procedure.There was no incision enlargement or sutures required.The patient's post-operative outcome was not available.No further information is available.

Manufacturer Narrative

Age, weight and ethnicity: per eu regulation (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.If implanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.(b)(6).Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.All pertinent information available to johnson and 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: 13564585
• MDR Text Key: 289745236
• Report Number: 3012236936-2022-00447
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558489
• UDI-Public: (01)05050474558489(17)231130
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/18/2022

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 Expiration Date: 11/30/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• 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
• Patient Outcome(s): Required Intervention