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

Model Number	PCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chemosis (1775); Corneal Edema (1791); Discomfort (2330)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt info: unk/not provided.Explant date: not applicable, as lens was not explanted.(b)(6).Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record evaluation: manufacturing record review (mrr) was conducted production order data shows that the product was manufactured and released according to specifications.A search of complaints was performed.No additional complaint was received from this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that patient underwent cataract extraction with intraocular lens (iol) implantation in the right eye.The surgery went smoothly.Postoperative eye drops were routinely performed.One day after operation, re-examination showed visual acuity of 0.6 in the right eye, conjunctival congestion, corneal detumescence, deep anterior chamber, tyn (tyndall) (+), and intraocular lens position.The other examination conditions were the same as admission, with intraocular pressure of 17.7 mmhg.Suspected body reaction to the iol in the eye.The patient was given prednisolone acetate eye drops 0.02ml tid (three times a day) in the right eye, tobramycin eye drops 0.02ml tid in the right eye, and compound tropicamide eye drops 0.02ml tid in the right eye for symptomatic treatment.On (b)(6) 2021, the patient returned to the hospital for re-examination: right eye 0.6, conjunctival congestion, corneal detumescence, anterior chamber depth, tyn (-), pupil diameter about 3 mm, intraocular lens position positive, the other examination conditions were the same as before, intraocular pressure 16.3 mmhg, the patient was given prednisolone acetate eye drops 6 times/day in the right eye and tobramycin eye drops 0.02ml 6 times/day in the right eye.The patient was asked to have outpatient re-examination one week later, and the patient visited the hospital in time for discomfort.One week later, the patient was re-examined, and the conjunctival congestion was eliminated and the inflammatory response was eliminated.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11874815
• Report Number: 2648035-2021-07880
• Device Sequence Number: 16426019
• Product Code: HQL
• UDI-Device Identifier: 05050474558335
• UDI-Public: (01)05050474558335(17)220719
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000235
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR